NRAC Issue #2068 - Steve's Marine Service

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NRAC Issue #2068 September 23, 2015 21 Pages

NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION

THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, DC

SUMMARY PAGE

MEDICAL DEVICES PRODUCT ACUSON SC2000 Ultrasound System MANUFACTURER Siemens Medical Solutions USA, Inc PAGE 5 PRODUCT Allura Xper FD MANUFACTURER Sony Medical Systems PAGE 19 PRODUCT CARTO VISITAG™ Module of the CARTO® 3 System MANUFACTURER Biosense Webster, Inc PAGE 19 PRODUCT Contra-Angles CA1:1L EVO 15 MANUFACTURER Bien Air Dental SA PAGE 16 PRODUCT Creatinine Reagent MANUFACTURER Pointe Scientific, Inc PAGE 17 PRODUCT CryoConsole MANUFACTURER Medtronic Inc Cardiac Rhythm Disease Management PAGE 17 PRODUCT Custom Cardiovascular Procedure Kit MANUFACTURER Terumo Cardiovascular Systems Corp PAGE 20 PRODUCT Dynamic Locking Screw System (DLS) MANUFACTURER Synthes (USA) Products LLC PAGE 3 PRODUCT Endoscope for the duodenum and upper GI tract MANUFACTURER Fujifilm Medical Systems USA, Inc PAGE 16 PRODUCT EVIS EXERA II Duodenovideoscope MANUFACTURER Olympus America Inc PAGE 5 PRODUCT Fluorescence Imaging Procedure Kits MANUFACTURER Intuitive Surgical, Inc PAGE 7 PRODUCT Gastrovideoscope MANUFACTURER Olympus America, Inc

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PAGE 19 PRODUCT LCD Monitors, 19 inch medical grade MANUFACTURER Sony Medical Systems PAGE 19 PRODUCT Lightspeed 16 CT, etc MANUFACTURER GE Healthcare PAGE 8 PRODUCT Medrad Mark 7 Arterion Injection System MANUFACTURER Bayer Healthcare PAGE 17 PRODUCT Merlin@home™ RF Remote Monitoring Transmitter MANUFACTURER St Jude Medical Cardiac Rhythm Management Division PAGE 18 PRODUCT MICroSTREP plus 1 and plus 2 Panels MANUFACTURER Beckman Coulter, Inc PAGE 19 PRODUCT Navigated Solera Screwdrivers MANUFACTURER Medtronic Navigation, Inc PAGE 18 PRODUCT neoBLUE® 3 LED Phototherapy System MANUFACTURER Natus Medical Inc PAGE 18 PRODUCT PenBlade Safety Scalpel MANUFACTURER Zien Medical Technologies, Inc PAGE 5 PRODUCT Processor EPX 2500 MANUFACTURER Fujifilm Medical Systems USA, Inc PAGE 18 PRODUCT Radiation Therapy Treatment Planning System Software MANUFACTURER Raysearch Laboratories AB PAGE 20 PRODUCT Tissue Processor MANUFACTURER Leica Microsystems, Inc PAGE 7 & 16 PRODUCT VersaCut+ Tissue Morcellator MANUFACTURER Lumenis PAGE 20

PHARMACEUTICALS PRODUCT Bactroban Nasal Ointment and Cream MANUFACTURER GlaxoSmithKline, LLC PAGE 21

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PRODUCT Cough Drops (menthol-cough suppressant) MANUFACTURER Bestco, Inc PAGE 21 PRODUCT ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose) MANUFACTURER Oasis Medical, Inc PAGE 21 PRODUCT Methocarbamol Tablets MANUFACTURER AustarPharma LLC PAGE 22 PRODUCT Ropivacaine HCl MANUFACTURER Pharmedium Services, LLC PAGE 21 PRODUCT Surgicept (ethyl alcohol 70% w/w) Waterless Surgical Hand Scrub & Healthcare Personnel Handwash MANUFACTURER DPT Laboratories, Ltd PAGE 21 ------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm RECALL NUMBER Z-2794-2015 CODE Part Numbers: 09.213.022S 09.213.024S 09.213.026S 09.213.028S 09.213.030S 09.213.032S

09.213.034S 09.213.036S 09.213.038S 09.213.040S 09.213.042S 09.213.044S

09.213.046S 09.213.048S 09.213.050S 09.213.052S 09.213.054S 09.213.056S

09.213.058S 09.213.060S 09.213.065S 09.213.070S 09.223.032S 09.223.034S

09.223.036S 09.223.038S 09.223.040S 09.223.042S 09.223.044S 09.223.046S

09.223.048S 09.223.050S 09.223.055S 09.223.060S 09.223.065S 09.223.070S

09.223.075S 09.223.080S 09.223.085S 09.223.090S

Lot Numbers: 2799588 2799590 2801042 2801043 2802483 2803970 2806031 2809073 2809673 2812544 2813042 2813043 2813065 2814722 2815303 2822441 2822442 7802259 7802261 7804003 7813305 7833918 7883446

2799592 2799804 2801040 2801041 2802484 2803971 2806032 2809075 2809668 2809669 2810870 2810896 2811588 2814723 2815305 2822443 7764728 7769461 7802262 7804004 7804005 7813306 2798572

2798573 2798574 2801019 2803150 2803361 2804799 2809077 2810267 2810268 2814724 2814725 2815307 2815308 2815837 2815838 2815840 2822033 2826534 7801003 7802263 7813307 7824108 7833920

7865322 7913562 8002399 2798708 2801020 2801021 2802485 2803145 2806033 2809078 2809079 2812546 2812547 2813044 2813045 2813770 2818115 2818116 2822034 2822836 2826536 7801004 7813309

7821406 7824110 7833922 7873469 7913565 2798709 2798710 2798711 2801044 2802481 2803151 2809311 2809312 2812548 2812549 2815841 2815842 2815843 2815844 2826537 2826538 7801006 7813311

7824111 7833923 7833926 7913568 7913570 8002411 2798713 2801022 2803152 2803362 2803363 2809313 2809314 2809664 2809665 2812832 2813046 2813047 2813761 2813763 2814733 2815312 2822035

2822036 2826540 7801012 7813313 7824112 7833929 7833930 7873486 2798715 2801023 2803153 2803364 2806034 2806035 2809317 2809318 2813048 2813049 2813064 2813771 2814736 2814738 2815313

2815315 7801017 7804006 7813314 7824113 7833932 7913572 7913578 2798240 2798717 2798718 2798719 2801024 2803365 2806036 2806037 2809666 2809667 2813050 2813063 2813756 2813757 2813766

2814739 2815317 2815318 2826541 7802266 7806983 7813315 7833933 7865323 7873470 7873471 2798720 2801025 2801026 2803366 2806038 2810269 2810270 2810271 2810273 2813051 2813776 2814741

2815319 2818117 2818606 2822838 2826544 2826824 2826825 7806984 7813317 7824114 7833937 7833948 7833949 7913637 7913641 2798721 2799594 2801027 2803367 2803368 2806039 2806040 2810329

2810331 2813052 2813053 2813758 2813760 2814746 2814751 2815320 2815321 7802282 7802284 7806985 7806986 7813319 7833975 7833976 8002499 8272594 2798722 2798723 2799757 2801028 2801029

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2803369 2803963 2808549 2810335 2810336 2810338 2812833 2813054 2813773 2813774 2814753 2815323 2826826 2826827 2826833 2826834 7726601 7726608 7802285 7804017 7813320 7833978 7833979 7873476 2799600 2801030 2801031 2803370 2803964 2804127 2806324 2806325 2810333 2810873 2811586 2813055 2813769 2814758 2818607 2822038 2822039 7801020 7804007 7813333 7824115 7824116 7833982 7873474 7873475 7913647 2799601 2799602 2801032 2803965 2803966 2806557

2806558 2810341 2810342 2812552 2812553 2813056 2813057 2813775 2814760 2815324 2822040 2822044 2826828 2826835 2826836 7804018 7813335 7824149 7833990 7913650 7913652 2799604 2801033 2803967 2803968 2810357 2810358 2810874 2810875 2812554 2812555 2814762 2814765 2814768 2814771 2815325 2819164 2819165 2826070 2826074 2826829 7806987 7806988 7813336 7834028 7913654 2798241 2799612 2801034 2802486 2804114 2808552 2809678 2809679 2810876 2812834

2813058 2813059 2813767 2814775 2815327 2822045 2822047 2826830 7802267 7802286 7806989 7813338 7824171 7834030 8002518 2800599 2801049 2801050 2802487 2806559 2809676 2809677 2810877 2811585 2819441 2826961 2826962 7726611 7782982 7802269 7804019 7813340 7826591 7834032 7834036 7913659 2800600 2802489 2804117 2804796 2809674 2809675 2810878 2813060 2819442 2826963 2826964 7726600 7782986 7782991 7802271 7804020 7813341 7834039 7836176 7836187

2800344 2802491 2802493 2804794 2809321 2810881 2810884 2810885 2813061 2826965 2826966 7782999 7783025 7802273 7804022 7813342 7836192 7836196 7836197 2800212 2802497 2802499 2804795 2810351 2810352 2810886 2810887 2810888 2813062 2826967 2826968 7726597 7726598 7783001 7801023 7806992 7813343 7836202 7836203 7836205 2799618 2801035 2804120 2804121 2804122 2804797 2810346 2810349 2810889 2810890 2812558 2812559 2813765 2814779 2815328 2815329

2822842 2822843 7802275 7806993 7806994 7813344 7836206 2799624 2799625 2801037 2802479 2804123 2809323 2809671 2809672 2810891 2810892 2812557 2815846 2815847 2815848 2815854 2822845 2822846 2826116 2826831 2826832 7804023 7813345 7824185 7836209 7873487 2799627 2799628 2801038 2801039 2804124 2804125 2804126 2804798 2809076 2809670 2810894 2810895 2812556 2813772 2815856 2815857 2815859 2815860 2822834 2822835 2822847 2822848 7811121 7811123

7813346 7836212 8002558 2783396 2783400 2786423 2792364 2795771 2795772 2804548 2805858 2805859 2807688 2807958 2815391 2815398 2818615 2818616 7721840 7721842 7754361 7816040 7816042 7849731 7849737 7913664 7913666 8002613 8002634 8349755 2783409 2783410 2786422 2792365 2795773 2795774 2804790 2807686 2807957 2808519 7722969 7722970 7722972 7755834 7755841 7755842 7781880 7814755 7816046 7816048 7913668 8002641 8002676 8271810 8349753 2778498

2778507 2778508 2783411 2783412 2786283 2792366 2793483 2795794 2804549 2807584 2807949 2815401 2819272 7722974 7722975 7722976 7755844 7761452 7814756 7816057 7816061 7849743 7913670 8002695 8002722 8002739 8271806 8349732 2748748 2749819 2778519 2792345 2793484 2804550 2804791 2804792 2805854 2805855 2807707 2811193 2815434 7722977 7740994 7759402 7759405 7803748 7806668 7807460 7811025 7849752 7849765 7849770 7868979 8002751 8271793 8271802

8340641 8340649 2748939 2749820 2778525 2778526 2778527 2792346 2793485 2795797 2805875 2805877 2805879 2805880 2807946 2808517 2811194 2818618 2818619 2826596 2826597 2826614 7719280 7803749 7807463 7811027 7826551 7833561 7849795 7849799 7849806 7868980 8271784 2748940 2749821 2786424 2786428 2792348 2795803 2804552 2804553 2805881 2805882 2807953 2807954 2808520 2815429 2815430 2826598 2826859 7806671 7807467 7811038 7826553 7849814 7849823

7868981 8340633 2763692 2763694 2773533 2778903 2792349 2793486 2795804 2804554 2806328 2806329 2806633 2807679 2819273 2826599 7754370 7759412 7806673 7807468 7811041 7826554 7913671 7913672 8340619 2749825 2773534 2778906 2778907 2792350 2793487 2795806 2806625 2807499 2807947 2826600 2826601 7740995 7754412 7777726 7803753 7807472 7811043 7833564 7864139 7913673 8002757 2748943 2748945 2773536 2792351 2793488 2795807 2805884 2806623 2806626

2807503 2807684 2807948 2826878 7719553 7719632 7754416 7806674 7807474 7811047 7826555 7864142 7913798 8002775 2748947 2749827 2778910 2778911 2792352 2793489 2795815 2804556 2807694 2807955 2822435 2822436 2826880 7719551 7806676 7807478 7811050 7826557 7833567 7833570 7913800 7913802 8002794 2748971 2749829 2773539 2782704 2782705 2792353 2793490 2795840 2804558 2806632 2807677 2807956 2808522 2819275 7806679 7807482 7811052 7849972 7851114

7851116 7864145 2748972 2749831 2778912 2778913 2778915 2786425 2786431 2792354 2793491 2806624 2806630 2807652 2807691 2819276 7759415 7767363 7807487 7811066 7826560 7826561 7868982 2748973 2751623 2780629 2780630 2792355 2793493 2804559 2806634 2807680 2815431 7719577 7719670 7740996 7740997 7759417 7803754 7806682 7807493 7811071 7833573 2748974 2751624 2792356 2793482 2795847 2804560 2804793 2806629 2807670 2807950 2811195 2818127 2818128

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2826603 2826608 2826616 7807500 7811074 7826564 7826571 7833575 7851120 7868985

2748975 2751625 2780632 2782706 2792357 2792358 2795848 2795849 2795850 2806628

2807673 2807951 2807952 2808523 2818621 2819277 7759418 7803755 7803756 7806685

7807503 7811111 7851126 2748976 2751626 2780633 2786427 2792359 2793496 2795851

2804562 2807696 2807959 2818622 2818623 2818624 2826604 2826607 2826618 2826619

2826620 7754421 7754469 7754473 7806688 7807505 7811112 7824208 7851129 2748977

2751632 2774564 2792360 2792361 2793498 2795853 2805895 2805898 2806631 2807676

2807700 2819278 2826605 2826606 2826621 7754428 7754435 7754439 7754440 7806694

7806696 7811113 7826573 8002802 2748978 2774563 2780637 2792362 2792363 2793499

2795855 2804563 2806627 2806635 2807682 2807683 2822430 2822431 2822433 2822434

7754443 7754444 7806698 7806701 7811114 7824213 7833578 7913810

MANUFACTURED & RECALLED BY Synthes (USA) Products LLC, West Chester, PA QUANTITY 40038 DISTRIBUTION Nationwide REASON Additional consignees identified related to complaint of breakage located at the bottom of

the screws and under the locking screw head. Injuries reported for precedent recall (Z-0390-2014), see MDRs.

------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT PenBlade Safety Scalpel RECALL NUMBER Z-2800-2015 CODE Models PB-M-10, PB-M-11P, PB-M-15; PenBlade Safety Scalpel, #10 blade, Code PBSS-

M-10; PenBlade Safety Scalpel, #11P blade, Code PBSS-M-11P; PenBlade Safety Scalpel, #15 blade, Code PBSS-M--15

MANUFACTURED & RECALLED BY Zien Medical Technologies, Inc, Salt Lake City, UT QUANTITY 28,284 DISTRIBUTION Nationwide and internationally REASON Cracks were discovered in the PET tray of a small population of sterile product. These

cracks create a risk of loss of sterile barrier for the product. ------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT EVIS EXERA II Duodenovideoscope RECALL NUMBER Z-2807-2015 CODE Model TJF-Q180V, all sold units MANUFACTURED & RECALLED BY Olympus America Inc, Center Valley, PA QUANTITY 6109 DISTRIBUTION Nationwide and internationally REASON New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V

duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.

------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT ACUSON SC2000 Ultrasound System RECALL NUMBER Z-2783-2015 CODE Software versions VB10B and lower; model 10433816: serial numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719

402310 402495 400308 400641 400770 401110 401114 401135 401136

401138 401169 401174 401176 401370 401406 401366 401460 401591

401750 401753 401793 401803 402090 402139 402177 402197 402255

402323 402327 402339 402351 402387 402492 402508 400261 400350

400763 400787 400789 400790 400791 400792 400794 400797 400881

400886 400888 400890 400892 400898 400923 400951 400978 401023

401025 401957 402451 400090 400066 400063 400868 400873 401041

401540 402109 400139 400141 400171 400235 400287 400291 400292

400293 400351 400337 400338 400458 400459 400475 400526 400527

400529 400583 400589 400593 400620 400693 400743 400843 400872

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400877 400878 400891 400895 400921 400958 400959 400960 400970 400989 401001 401012 401029 401031 401044 401065 401075 401081 401083 401130 401132 401139 401187 401237 401243 401271 401286 401291 401305 401426 401441 401445 401590 401662 401725 401728 401744 401746 401758 401810 401832 401841 401863 401910 401969 402011 402027 402050 402051 402131 402190 402226 402242 402243 402244 402257

402260 402275 402296 402396 402398 402444 400720 400100 400492 400914 401108 401109 401255 401638 401641 401845 402279 400065 400715 400174 400440 400448 400538 400541 400572 400615 400622 400623 400626 400799 400830 400882 400931 401049 401115 401375 401285 401343 401397 401402 401409 401424 401425 401430 401570 401730 401734 401991 402026 401890 401898 401899 401906 400029 400195 400070

400223 400224 400233 400309 400454 400456 400530 400552 400617 400814 400818 400835 401204 401281 401476 401547 401565 401567 401568 401602 401612 401900 401950 401959 401961 402280 402322 402341 402449 401173 401289 400472 401501 401507 401552 401600 401705 401797 401825 401837 402236 402386 400822 400676 400678 400665 400683 400145 400179 400310 400311 400968 401378 401446 401497 400175

400226 400236 400245 400244 400264 400267 400269 400283 400288 400297 400536 400629 400640 400679 400680 400717 400757 400759 400768 400773 400775 400788 400795 400800 400832 400848 400874 400883 400884 400885 400905 400967 400974 401028 401111 401258 401265 401266 401278 401379 401384 401386 401391 401348 401423 401429 401550 401491 401494 401572 401584 401592 401610 401621 401636 401639

401674 401678 401732 401737 401747 401862 401864 401867 401872 401918 401987 402025 402028 402081 402118 402200 402215 402216 402320 402407 402448 402481 400220 400221 400435 400437 400451 400767 400803 400821 400862 400986 401177 401453 401462 401574 401575 401765 402406 402489 401040 400570 401007 401010 401020 401235 401252 401520 401564 401611 401804 401846 402030 402336 402454 402476

402500 402513 402511 401691 401771 402143 402271 402273 402290 402306 402325 400442 400486 400487 400489 400564 400998 400999 401979 402029 400449 401562 401597 401648 402094 400048 400118 400132 400143 400295 400093 400431 401216 400299 400023 400120 400126 400265 400326 400069 400480 400485 400550 400689 400700 400691 400742 400786 400893 400913 400979 401112 401373 401315 401351 401461

401625 401631 402023 402031 402048 402258 402313 402319 402332 402357 402391 402431 402484 400088 400123 400137 400152 400197 400234 400312 400436 400477 400669 400817 400929 400972 401054 401055 401067 401071 401503 401836 402010 402018 402022 402056 402125 402127 402145 402168 402214 402220 402222 402228 402230 402253 402254 402318 402333 402337 402354 402377 402421 402412 401708 400483

400484 400513 400535 400847 401003 401013 401014 401134 401234 401256 401369 401392 401410 401539 402316 402317 402330 402334 402345 402397 402399 402375 400024 400022 401250 401322 401323 401327 401433 401124 401458 401533 401553 401656 401660 402223 400336 400196 400464 400671 400988 401194 401247 401500 401405 401346 401710 401713 401760 401769 401787 401859 401881 401883 401902 401915

401916 401917 402077 402102 402229 402256 402268 402287 402315 401645 401774 402064 402285 402453 402447 402417 400108 400135 400138 400156 400177 400203 400222 400228 400246 400313 400318 400317 400322 400324 400446 400452 400455 400457 400465 400471 400496 400621 400650 400663 400664 400668 400667 400675 400698 400899 400991 401015 401030 401078 401090 401175 401246 401241 401248 401249

401345 401404 401360 401475 401573 401599 401628 401751 401782 401821 401839 401849 401850 401847 401855 401856 401857 401860 401877 402086 402175 402248 402250 402282 402305 402379 402411 402400 400117 400131 400084 400176 400712 400716 400907 400953 400964 401008 401070 401244 401361 401629 401801 401827 401878 401880 402249 402262 401444 400128 400142 400163 400086 400672 400708 400736

400782 400810 400811 400887 400889 401043 401069 401155 401156 401181 401182 401193 401226 401245 401267 401268 401269 401279 401280 401287 401554 401586 401868 401885 401940 402014 402049 402057 402082 402087 402095 402192 402382 402392 402371 402374 402429 400067 400595 400613 400894 400940 400954 400955 400962 401802 402154 400662 400674 400687 400813 401116 401236 401257 401320 401559

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401576 402041 402219 400122 400168 400194 400081 400204 400229 400230 400314 400316 400346 400438 400460 400461 400462 400463 400466 400467 400470 400479

400493 400501 400516 400519 400520 400545 400638 400666 400829 400851 400852 400855 400857 400956 400944 400994 400997 400965 401011 401022 401088 401080

401117 401141 401149 401158 401184 401300 401290 401308 401311 401314 401319 401326 401333 401335 401336 401383 401347 401365 401422 401438 401440 401557

401578 401616 401633 401653 401683 401693 401700 401729 401733 401799 401873 401882 401914 401927 402012 402020 402021 402054 402191 402264 402353 402369

402376 402436 400930 401190 400517 400740 401137 401363 401364 401583 400860 400875 400912 400925 400225 400404 400355 400474 400634 400900 400902 400154

400153 400258 400303 400304 400528 400548 400555 400992 401061 401282 401328 401385 401387 401407 401427 401450 401493 401569 401607 401608 401618 401669

401697 401706 401711 401724 401772 401776 401800 401826 401830 401840 401843 401848 401851 401879 401889 401892 401907 401911 401929 401943 401981 402068

402083 402089 402237 402238 402283 402286 402303 402307 402326 402423 402420 402457 402478 402501 400554 400694 400630 400102 400162 400861 400985 401089

401538 401558 401587 401644 402312 402338 402418 401680 400124 400227 400473 400577 400649 401505 401294 401727 401813 402078 402206 402211 402233 402252

402299 402439 402456 402496 402499 400050 401561 401655 402162 400130 400129 400481 400573 400610 400618 400776 400820 401198 401213 401307 401432 401474

401489 401596 401735 401741 401743 401795 401838 401908 401919 401922 402266 402278 402284 402289 402301 402413 402514 401063 401436

MANUFACTURED & RECALLED BY Siemens Medical Solutions USA, Inc, Mountain View, CA QUANTITY 2039 devices DISTRIBUTION Nationwide and internationally REASON The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the

same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips.

------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems RECALL NUMBER Z-2782-2015 CODE Product number 950156-01; lot numbers NQ141201, NQ141502, NQ142201, NQ142901,

NQ143201, NQ143301; product number 950156-02; lot numbers NQ143501, NQ143502, NQ143601, NQ143602, NQ143803, NQ143901, NQ143902; product number 950156-03; lot numbers NQ144001, NQ150501, NQ143902, NQ150601, NQ143901, NQ150602, NQ143803, NQ150703, NQ143601, NQ150701, NQ143602, NQ150702, NQ144502, NQ150801, NQ144801, NQ150901, NQ145202, NQ150802, NQ144901, NQ151001, NQ145301, NQ151002, NQ145201, NQ151101, NQ150301, NQ150501, NQ144001

MANUFACTURED & RECALLED BY Intuitive Surgical, Inc, Sunnyvale, CA QUANTITY 1200 kits DISTRIBUTION Nationwide REASON Internal investigation found that B Braun 2 gang 4-way stopcocks provided within the

Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Tissue Processor RECALL NUMBER Z-2779-2015 CODE Product code ASP200S/ASP300S, serial numbers 5682; 5886; 5264; 5267; 5356; 5259;

5956; 5946; 5794; 5385; 5929; 5301; 5401; 5310; 5530; 5909; 5804; 5272; 5724; 5796; 5807; 5446; 5435; 5670; 5947; 5348; 5434; 5388; 5366; 6000; 6131; 5407; 6040; 5799;

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5815; 5737; 5706; 5381; 5416; 5673; 5875; 5962; 6041; 6042; 5266; 5948; 5693; 6021; 5610; 5798; 5926; 5387; 5349; 5273; 6115; 5612; 5965; 5955; 5260; 5725; 5871; 5873; 5874; 5562; 6046; 5386; 5977; 5889; 5398; 6062; 5609; 6015; 5734; 5403; 5289; 5426; 6149; 5663; 6045

MANUFACTURED & RECALLED BY Leica Microsystems, Inc, Buffalo Grove, IL QUANTITY 901 DISTRIBUTION Nationwide and internationally REASON An incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to

not function correctly in the case of an instrument failure. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT 1) Lightspeed 16 CT RECALL NUMBER Z-2801-2015 PRODUCT 2) PET Discovery LS RECALL NUMBER Z-2802-2015 PRODUCT 3) PET Discovery ST 16 RECALL NUMBER Z-2803-2015 CODE 1) 00000058433HM4 4860LS16GS FMI25463004 910213080 FMI25463005 910212101 FMI25463006 910212105 FMI25463007 910213064 FMI25463008 910216041 FMI25463009 910216036 00000321402CN0 910212106 00000325191CN5 AH5362CT02 FMI25463010 190020CT03 FMI25463011 110807CT01 00000980106YM9 110040CT03 00000307018CN2 416249LS16 00000298660CN2 204787LSPD2 00000318927CN1 514468BLS 00000329994CN8 819561LS 00000389961CN4 709891CT 00000335314CN1 514934CLS16 00000340630CN3 82421140148 00000331165CN1 82421010103 00000336002CN1 82421130067 00000334898CN4 82421140150 00000322331CN0 82421160145 00000999187YM8 82421100291 FMI25463133 828210047 FMI25463136 82421310073 00000989604YM4 82421030247 FMI25463015 82421010063 00000075153HM7 82421120171 FMI25463016 082421ATCLSP04 FMI25463017 82421100443 00000080677HM8 82421090111 00000092789HM7 82421120191 00000092771HM5 82421120188 00000074379HM9 82421060038 FMI25463018 82421130055 00000092530HM5 82421110048

9

00000080298HM3 82421100270 FMI25463019 395291CT01 FMI25463020 PM1633CT04 FMI25463021 PC7479CT02 FMI25463022 DK1025CT02 00000420281CN8 NP384114 FMI25463023 FI2000MN01 00000953833YM1 FI1052CT02 FMI25463024 C6010809 FMI25463025 M1076839 FMI25463026 M40345153 FMI25463027 M4496936 FMI25463028 M4409416 FMI25463029 M2147233 FMI25463030 M4505261 FMI25463031 M4020535 FMI25463032 M4491526 FMI25463033 M2802781 FMI25463034 X971285001 FMI25463035 A4463317 FMI25463036 B4195716 00000320672CN9 M4160064 00000271501CN9 M4182817 00000302750CN5 HC3314CT02 00000311056CN6 PC1268CT03 00000980113YM5 PROS01CT04 00000309302CN8 HC3428CT02 00001033124YM7 HC1560CT05 00000031399CN5 CC0618CT03 00000301205CN1 HC1627CT04 00000000716YC1 PX2261CT02 FMI25463041 GOLD010271 FMI25463042 GOLD010160 00000297465CN7 HU1039CT03 00000313648CN8 HU1008CT02 FMI25463043 835210046 FMI25463045 83021842100841 00000475152YM5 83097598280000 FMI25463046 83021002101343 FMI25463047 83021002101503 FMI25463048 83037594099999 00000342119CN5 83021042101703 00000319062CN6 83021200019012 00000326255CN7 83021002100903 FMI25463134 IL1041CT01 FMI25463044 IL1000CT01 FMI25463049 A5177356 00000974327YM9 A5415714 FMI25463050 A5375119 00000297467CN3 A5315535 00000298788CN1 A5404503 00000298327CN8 A103421302 00000317806CN8 A5152959 00000298364CN1 A5109820 00000317976CN9 QW3044 00000277446CN1 QY0024

10

00000941020YM0 QW3077 00000311054CN1 QW3036 00000953849YM7 QWZ057 00000941010YM1 XF0018 00000953829YM9 QT3033 00000980097YM0 QW3059 00000305242CN0 QW2025 00000988399YM2 QW3064 00000297463CN2 QY0006 00000953847YM1 QT3036 00000304158CN9 QY0002 00000310122CN7 QY0058 00000980099YM6 QZ0001 00000941033YM3 QT3032 00000303514CN4 QW3033 00000988404YM0 XF0149 00000994079YM2 QT4051 00000980096YM2 QT4049 00000941031YM7 QT3031 00000328077CN3 QW3045 425784CN6 HD0041 33373GM2 RY0028 239249HM6 BD9217 FMI25463051 QT4074 FMI25463052 QT3042 FMI25463053 XF0022 FMI25463054 QW3049 00000296397CN3 QW2016 FMI25463055 QZ0120 00000004875YC1 QZ0066 FMI25463056 YN0382 FMI25463057 QW3057 00000297397CN2 QW3043 00001023672YM7 QW3073 00000314641CN2 850210549 00000067961HM3 850210557 00000071678HM7 850210558 00000086904HM0 850210826 00000066382HM3 850210555 00000392647CN4 LSPRO2643765 00000295414CN7 73801LS16S 00000307947CN2 NO1052CT02 00000286517CN8 604853CTLS FMI25463135 600042CT01 FMI25463058 809780EXCITE FMI25463059 SA1279CT01 00000296276CN9 SA1011CT02 FMI25463060 Z001CT02 1380806 847210020 00000303589CN6 SK1003CT01 00000310270CN4 ZA1247CT01 00000994088YM3 ZA1127CT02 00000318926CN3 ZA2471CT01 00000205583HM8 ZA1058CT02 00000309308CN5 DEN27243 00000030411CN8 DPM32132

11

00000329991CN4 DEL89957 00000329306CN5 DE188430 00000310874CN3 MPX02003 00000327272CN1 DEL26410 00000297385CN7 DPB15832 00000304109CN2 FPG08400 00000297902CN9 FPG03601 00000279527CN6 FPG81004 00000299766CN6 A010CT07 00001033115YM5 547110CT02 FMI25463012 475230CT04 FMI25463013 120928CT01 FMI25463014 115030CT01 00000312924CN4 00160CTS02 00000336000CN5 10649CTS01 00000294856CN0 00361CTS02 00000984693YM2 00664CTS02 00000302754CN7 10628CTS01 313653CN8 70328CTS03 FMI25463037 00537CTS01 FMI25463038 80040CTS02 FMI25463039 00314CTS02 FMI25463040 10470CTS01 309307CN7 SHICT18 00000312257CN9 503215PCT4 00000293010CN5 503DRCCT 00000296272CN8 518828CT 00000323860CN7 ALLIANCECT74 00000318314CN2 949949CT 00000310267CN0 715453CT1 00000317790CN4 612863LSC 00000321966CN4 732671LS16 00000338403CN9 850718JLS 00000336255CN5 702880CT 00000339629CN8 914681PRO 00000334464CN5 RADNETCT1483 00000297390CN7 518438LS16 00000362635CN5 615320CT 00000341886CN0 305285LS 00000314491CN2 252847CT3 00000321140CN6 773792PRO 00000331769CN0 775785CT16 00000320666CN1 972548LS16 00000313370CN9 434243UVICT1 00000311424CN6 770751QXI 00000297382CN4 206232CT1 00000299234CN5 RADNETCT1500 00000292531CN1 423272CT 00000296274CN4 574371CT16 00000288654CN7 703385LS16 00000277800CN9 415723SCT3 00000348034CN0 410337LS16 00000318730CN9 480237CT16 00000328358CN7 4147614XCT1 00000338570CN5 304526LSPRO 00000308842CN4 813870LS16

12

00000307026CN5 847437ACT4 00000332709CN5 940384MDCT 00000347365CN9 770736LCT 00000314952CN3 718918LS16 00000293011CN3 CT81441 00000313365CN9 706845WGLS 00000308983CN6 918494SFLS2 00000297426CN9 412777LS16 00000307024CN0 956969CT 00000324976CN0 770778CTP16 00000318876CN0 918683LS16 00000338401CN3 617355CT3 00000294503CN8 770718OCT1 00000347517CN5 509248VCT16 00000319953CN6 757886CT 00000351700CN0 RADNETCT1404 00000294766CN1 402481BWCT1 00000323330CN1 804864BRLS16 00000315054CN7 907729CTPRO 00000293499CN0 212860LS16 00000299763CN3 208467CTLS 00000299311CN1 910215MR16 00000320667CN9 281PERWCT 00000313649CN6 423586CT2 00000294504CN6 949760CT2 00000321162CN0 760775CT 00000298790CN7 ALLIANCECT67 00000300371CN2 573635SMCT2 00000299765CN8 703578LS16 00000331098CN4 425261CT 00000342628CN5 773967LS16 00000304113CN4 276666CT 00000293037CN8 631475LS16 00000295005CN3 785452SCT 00000296280CN1 805SVCT1 00000336852CN9 772335CT1 00000362634CN8 570522CT1 00000351636CN6 845334LS 00000316660CN0 402887CT16 00000308839CN0 309672MCT1B 00000349343CN4 281395LS16 00000320654CN7 352728FHVC1 00000295410CN5 919731CT16 00000333823CN3 330830LS16J 00000332736CN8 206731ERCT 00000308361CN5 972420LS16 00000329988CN0 912692LS3 00000346883CN2 281FCLPCT 00000349345CN9 605342RCMC 00000298345CN0 734240CT16 00000323050CN5 781340SCT4 00000332081CN9 401769WLS 00000310731CN5 904391CTLS 00000326112CN0 406293LCT 00000317788CN8 ALLIANCECT127 00000311417CN0 281274CT3

13

00000366432CN3 253944CT16 00000342587CN3 207777LS16 00000320668CN7 724537CTLS 00000301084CN0 914737CTLS 00000294344CN7 504873TL16 00000350494CN1 303695LS16 00000298360CN9 210292LSA 00000314950CN7 913541CT16 00000338127CN4 801773CT2 00000288959CN0 812471CT 00000285030CN3 843236CFCT 00000290655CN0 937534CT 00000843255YM1 916RASCCT 00000886944YM8 336433KV16 00000327821CN5 918294SCLS FMI25463001 412469CTH1 00000358633CN6 815338PRO 00000886897YM8 912355LS16 00000273706CN2 423698DLS 00000281948CN0 SHICT288 00000361749CN5 503513PCT16 00000289411CN1 812537LS16 00000279106CN9 302653LS16 00000267340CN8 513856CT 00000279054CN1 609652LS16 00000271998CN7 817551OPCT 00000176078HM4 989839RT16 FMI25463002 610270LSPRO 00000265944CN9 940328LS16 00000296243CN9 925813CTM 00000919623YM9 912748CT1 00000265771CN6 918224LSCT 00000278570CN7 478745CT 00000328341CN3 863687LS8ER 00000385174CN8 814624LS1 00000367539CN4 432685LS1 00000843223YM9 RADNETCT1503 FMI25463003 860444CTPRO 00000381259CN1 303340CTHP 00000285331CN5 850747GCCT 00000276921CN4 704362MQCT 00000376596CN3 775885PRO 00000269963CN5 903TSJCT16 00000379714CN9 208455CTLS 00000295008CN7 214345LS16 00000984695YM7 515247CT5 00000386311CN5 623207CT16 00000988390YM1 864225CT 00000984689YM0 9167345X 953828YM1 SHICT19 00000953839YM8 305592LS16 00000358180CN8 505848LCT 00000313368CN3 609584LS16 00000387780CN0 631MSKLS16 00000314494CN6 713566LCT2 00000350423CN0 904824FCT4

14

00000365567CN7 208524PETCT 00000382184CN0 252641HCT16 00000328883CN4 317745LSPRO 00001030388YM1 816691PCT2 00000360963CN3 858657RTCT 00000984696YM5 901726CT2 00000365453CN0 907459TVCT 00000317093CN3 940384LS16 00000766980YM7 205601BHCT 00000263412HM9 716UROCT 00000940961YM6 845887LS16 00000412581CN1 414541VCT1 00000300854CN7 605882CT 00000308734CN3 00000074379HM9 00000315227CN9 607734H16 00000313363CN4 765423LS16 00000308836CN6 214345LINUX16 00000330532CN3 561650CT1 00000298793CN1 847LS16CT1 00000882908YM7 919CHTMCT 00000345928CN6 718920LSRO FMI25463061 760242LS16 FMI25463062 DCOSDI200000094 FMI25463063 423224CT2 FMI25463064 435251CT1 FMI25463065 281258PERMB FMI25463066 DCOSDI400000077 FMI25463067 ALLIANCECT103 FMI25463068 ALLIANCEPCT85A FMI25463069 580323LSP FMI25463070 510889CT FMI25463071 215481LS16 FMI25463072 716839LS16 FMI25463073 617726PR12 FMI25463074 662538CT FMI25463075 916734CT1 FMI25463076 425261CT2 FMI25463077 DCOSDI100000086 FMI25463078 630325DLS FMI25463079 516520LS16 FMI25463080 812450PRO100 FMI25463081 SHAREDPET2 FMI25463082 717273CT1 FMI25463083 301496CTPET FMI25463084 972579L16A FMI25463085 608364ERCT FMI25463086 605622CT1 FMI25463087 716898CT FMI25463088 6036503T FMI25463089 720FCACT1 FMI25463090 662756CT FMI25463091 915EPDST1 FMI25463092 918786LS1 FMI25463093 435734CT2 FMI25463094 212639LS03 FMI25463095 706316CT1

15

FMI25463096 DCOSDI100000423 FMI25463097 765646LS16 FMI25463098 201330LS16 FMI25463099 715387CT2 FMI25463100 404329LS16 FMI25463101 DCOSDI200000112 FMI25463102 916784CT1 FMI25463103 DCOSDI000000343 FMI25463104 717633CT2 FMI25463105 313916LS16 FMI25463106 317582LSPRO FMI25463107 SMRDST6 FMI25463108 304255LS16 FMI25463109 DCOSDI300000210 FMI25463110 3411 FMI25463112 901729MSCT FMI25463113 209536CT1 FMI25463114 ALLIANCEPCT71P FMI25463115 303398CTLS16 FMI25463116 916734CT2 FMI25463117 724832CT FMI25463118 MISECT33L FMI25463119 734936CT1 FMI25463120 3155 FMI25463121 915670HLS2 FMI25463122 205759CTI2 FMI25463123 308537GH16 FMI25463124 870972LS16 FMI25463125 276679CTLS FMI25463126 317846LS FMI25463127 952924CT1 FMI25463128 206731CT1 FMI25463129 956350VRCT FMI25463130 847ARLS FMI25463131 610954CT16 FMI25463132 608263CT3 FMI25463137 919684B5A FMI25463138 919684C3A FMI25463139 319272LS16 FMI25463140 408757LS16 FMI25463141 630275LSER FMI25463142 760830CT FMI25463111 DCOSDI000000013 2) 00000336259CN7 82445150008 00000357522CN2 RADNETPT608 00000316259CN1 210351MSDLS 00000293036CN0 352597PET 00000843236YM1 607766DLSPET 00000003458PT7 337407DLS 3) 00000407058CN7 B5127901 00000393804CN0 YE0524 00000007118PT3 A098PE01 00000005880PT0 853450026 00000295121CN8 469525DLS 00000331760CN9 256327PET 00000305946CN6 201599DST

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00000314955CN6 RADNETPT1813 00000362166CN1 203694DST16 00000354677CN7 918744PETCT 00000359856CN2 713704DST 00000364001CN8 845454PCT 00000299430CN9 817927DST 00000011079PT1 662232DST 00000005835PT4 256705PS2 00000010481PT0 615320DST 00000005903PT0 856794DISCST 00000412917CN7 818DCCDST MANUFACTURED & RECALLED BY GE Healthcare, Waukesha, WI QUANTITY 1) 416, 2) 6, 3) 18 DISTRIBUTION Nationwide and internationally REASON This is an update for a field correction posted on 7/21/15. Potential for expulsion of the

Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT Endoscope for the duodenum and upper GI tract RECALL NUMBER Z-2778-2015 CODE Product number: ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part

#202B1260196A; ED-450XT5 - Part #202B1260211A; ED-450XL5 - Part #202B1237681 MANUFACTURED & RECALLED BY Fujifilm Medical Systems USA, Inc, Wayne, NJ QUANTITY 256 units DISTRIBUTION Nationwide and internationally REASON FMSU-ESD has become aware of events in which the suction button on the ED-530XT

endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.

------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT Tissue Processor RECALL NUMBER Z-2804-2015 CODE Product Code Leica ASP6025; Serial Numbers: 163, 169, 200-729, 731, 733, 735, 737, 739,

741, 743, 745, 747, 749, 751, 753, 755, 757, 759, 761, 763, 765, 767, 769, 771, 773, 775, 777, 779, 781, 783, 785, 787, 789, 791, 793, 795, 797, 799, 801, 803, 805, 807, 809, 811

MANUFACTURED & RECALLED BY Leica Microsystems, Inc, Buffalo Grove, IL QUANTITY 163 systems DISTRIBUTION Nationwide and internationally REASON Product is incorrectly getting into a state of “bottle empty” during retort filling, after passing

the fill level sensor 2 and prior to reaching level sensor 3, thus not completing a 5 liter fill. ------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT Contra-Angles CA1:1L EVO 15 RECALL NUMBER Z-2797-2015 CODE Catalog numbers: 1600939-001, 1600938-001; Serial numbers concerned: Ref: 1600939-

001: Serial numbers included in the following range: 15B0001 up to 15F0011; Ref: 1600938-001: Serial numbers included in the following range: 15B0007 up to 15F0027

MANUFACTURED & RECALLED BY Bien Air Dental SA, Biel/bienne, Switzerland QUANTITY 112 (US) DISTRIBUTION Nationwide and internationally REASON Bien-Air Dental SA is recalling Contra-Angles CA1:1L EVO 15 because of possible

loosening of the dental tool, which may lead to potential swallowing of it.

17

------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT CryoConsole RECALL NUMBER Z-2777-2015 CODE Models 106A3, 106E2, 106A2-K; serial numbers: 5K0005, 5K0006, 5K0007, 5K0009,

5K0010, 5K0011, 5K0012, 5K0013, 5K0014, 5K0015, 5K0016, 5K0017, 5K0018, 5K0019, 5K0020, 5K0021, 5K0022, 5K0023, 5K0024, 5K0025, 5K0026, 5K0027, 5K0028, 5K0029, 5K0030, 5K0031, 5K0032, 5K0033, 5K0034, 5K0035, 5K0036, 5K0037, 5K0039, 5K0040, 5K0041, 5K0042, 5K0043, 5K0044, 5K0045, 5K0046, 5K0047, 5K0048, 5K0053, 5K0054, 5K0056, 5K0057, 5K0058, 5K0059, 5K0062, 5K0063, 5K0064, 5K0065, 5K0066, 5K0067, 5K0068, 5K0069, 5K0070, 5K0071, 5K0072, 5K0073, N5923, N5924, N5925, N5929, N5930, N5931, N5932, N5933, N6106, N6119, N6210, N6720, N7763, N7764, N7765, N7766, N7767, N7768, N7769, N7770, N7771, N7772, N7773, N7774, N7775, N7776, N7777, N7778, N7779, N7780, N7781, N7782, N7783, N7784, N7785, N7786, N7787, N8029, N8030, N8031, N8033, N8034, N8035, N8038, N8039, N8040, N8041, N8042, N8043, N8044, N8045, N8046, N8047, N8048, N8049, N8050, N8051, N8052, N8053, N8054, N8055, N8056, N8057, N8058, N8059, N8060, N8061, N8062, N8063, N8064, N8065, N8067, N8068, N8069, N8070, N8072, N8073, N8074

MANUFACTURED & RECALLED BY Medtronic Inc Cardiac Rhythm Disease Management, Saint Paul, MN QUANTITY 106 units DISTRIBUTION Nationwide and internationally REASON Medtronic has identified an issue with a USB memory component contained within a subset

of CryoConsoles. The issue can result in extended procedure time. ------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT Creatinine Reagent RECALL NUMBER Z-2773-2015 CODE Catalog number: C7539-150, Lot: 406201, Batch: 279, Expiration date: 2016-03 MANUFACTURED & RECALLED BY Pointe Scientific, Inc, Canton, MI QUANTITY 93 kits DISTRIBUTION Nationwide and internationally REASON Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine

reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.

------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT Medrad Mark 7 Arterion Injection System RECALL NUMBER Z-2775-2015 CODE Catalog numbers: ART 700 PEDL, ART 700 TABL, ART 700 OCS; serial numbers: 20329,

20570, 101148, 20392, 20425, 20427, 30046, 100945, 100186, 21255, 30086, 20025, 101153, 101159, 20714, 100873, 20437, 100033, 100249, 20333, 100511, 101206, 100002, 100890, 101208, 20323, 20914, 20342, 10172, 10074, 20195, 20196, 20850, 20929, 101106, 30020, 30024, 30033, 20252, 10087, 20851, 100009, 100864, 100335, 10095, 20302, 20306, 100013, 20918, 100141, 20158, 100784, 20735, 20422, 101149, 20842, 20018, 101114, 100056, 100075, 20434, 21024, 20311, 20763, 10055, 20786, 20701, 20729, 20040, 100092, 20501

MANUFACTURED & RECALLED BY Bayer Healthcare, Indianola, PA QUANTITY 71 DISTRIBUTION Nationwide and internationally REASON Certain Medrad Mark 7 Arterion Injection Systems, which utilize Software Version SW

005.006_SH, have a potential situation involving the purge enforcement procedure. This recent software revision has resulted in the removal of purge enforcement from traditional

18

New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position.

------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT 1) Processor EPX 2500 Operation Manual RECALL NUMBER Z-2805-2015 PRODUCT 2) Processor EPX 2500 High Definition Endoscopy Sales Brochure RECALL NUMBER Z-2806-2015 CODE Part Numbers: 1) 202B1230408A, 202B1230408B, 202B1230408C, 202B1230408D,

202B1230408E; 2) 2500.0312.00, 2500.0312.01 MANUFACTURED & RECALLED BY Fujifilm Medical Systems USA, Inc, Wayne, NJ QUANTITY 60 DISTRIBUTION Nationwide and internationally REASON Fujifilm Medical Systems has become aware that the EPX-2500 Operation Manual and sales

brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor.

------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT Navigated Solera Screwdrivers RECALL NUMBER Field correction CODE Part Numbers: Screwdrivers – 9735023, 9735024, 9735025, 9735026, 9735027, 9734856,

9734857, 9734279, 9734373; Kits – 9735283, 9735283-G02, 9734632, 9734647, 9734648, 9735281, 9735278, 9735282, 9735279, 9735280

MANUFACTURED & RECALLED BY Medtronic Navigation, Inc, Louisville, CO QUANTITY Not available at publication DISTRIBUTION Nationwide REASON The potential for the tips to break during use. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Merlin@home™ RF Remote Monitoring Transmitter RECALL NUMBER Update to prior notice CODE Model EX1150 MANUFACTURED & RECALLED BY St Jude Medical Cardiac Rhythm Management Division, Sylmar, CA QUANTITY Not available at publication DISTRIBUTION Nationwide REASON This is an update to recall #Z-0949-2015 posted on 1/12/2015. St Jude Medical identified

that a second software anomaly coexisted in the Merlin@home system that also had the potential to cause software resets for St Jude Medical devices.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT neoBLUE® 3 LED Phototherapy System RECALL NUMBER Safety notice CODE All MANUFACTURED BY Natus Medical Inc, San Carlos, CA RECALLED BY Hill-Rom, Inc, Batesville, IN QUANTITY Not available at publication DISTRIBUTION Nationwide REASON Changes have been made to the user and service manuals related to Intensity for the

neoBLUE® system. -----------------------------------------------------------------------------------------------------------------------------------------------

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PRODUCT MICroSTREP plus 1 and plus 2 Panels RECALL NUMBER To be determined CODE B1027-201: 2016-01-27, 2016-02-27, 2016-03-26, 2016-04-02, 2016-04-14, 2016-05-01,

2016-05-15, 2016-06-12; B2017-202: 2016-01-30, 2016-03-23 MANUFACTURED & RECALLED BY Beckman Coulter, Inc, Miami, FL QUANTITY Not available at publication DISTRIBUTION Nationwide REASON Beckman Coulter has received reports regarding ampicillin and penicillin false resistance

with clinical isolates and out-of-range (high) quality control (QC) results. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Gastrovideoscope RECALL NUMBER Field correction CODE GF-UCT180 MANUFACTURED & RECALLED BY Olympus America, Inc, Center Valley, PA QUANTITY Not available at publication DISTRIBUTION Nationwide REASON To provide revised labeling that describes certain accessories and parts. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT CARTO VISITAG™ Module of the CARTO® 3 System RECALL NUMBER Safety notice CODE All MANUFACTURED & RECALLED BY Biosense Webster, Inc, Diamond Bar, CA QUANTITY Not available at publication DISTRIBUTION Nationwide REASON To reinforce the importance of proper use of the Force Time Integral (FTI) setting. To

reinforce the following warning, which appears in the CARTO® 3 System Instructions for Use: The CARTO VISITAG™ Module provides access to data collected during the application of RF energy. The data does not indicate the effectiveness of RF energy application.

-----------------------------------------------------------------------------------------------------------------------------------------------

PRODUCT Allura Xper FD RECALL NUMBER Field correction CODE 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036,

722039, 722059 MANUFACTURED & RECALLED BY Philips Healthcare, Andover, MA QUANTITY Not available at publication DISTRIBUTION Nationwide REASON In certain circumstances a software error can lead to a situation where the five minute

fluoroscopy audible signal does not sound. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT LCD Monitors, 19-inch medical grade RECALL NUMBER Z-2771-2015 CODE Sony LMD-1951MD: 3000038-3004884, 3100035-3100058, 3100065-3100145 MANUFACTURED & RECALLED BY Sony Medical Systems, Park Ridge, NJ QUANTITY 1016 DISTRIBUTION AZ, CA, FL, IA, NC, OH, PA

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REASON Sony Electronics Inc is recalling LMD-1951MD 19 inch medical grade liquid crystal display (LCD) monitors with light-emitting diode (LED) backlight technology since the medical monitor has either not turned on or has lost image during clinical use.

------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT VersaCut+ Tissue Morcellator RECALL NUMBER Z-2770-2015 CODE GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System

with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.

MANUFACTURED & RECALLED BY Lumenis, Yokneam, Israel QUANTITY 54 devices with 108 hand pieces DISTRIBUTION CA, PA, MA, FL, NY REASON There is a probability the hand piece may operate inconsistently and unpredictably during

the morcellation procedure resulting in damage to non-target tissue. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT 1) Custom Cardiovascular Procedure Kit Tubing Pack RECALL NUMBER Z-2786-2015 PRODUCT 2) Custom Cardiovascular Procedure Kit X-Coated Adult Pak RECALL NUMBER Z-2787-2015 PRODUCT 3) Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE RECALL NUMBER Z-2788-2015 PRODUCT 4) Custom Cardiovascular Procedure Kit X-Coated RECALL NUMBER Z-2789-2015 PRODUCT 5) Custom Cardiovascular Procedure Kit X-Coated RECALL NUMBER Z-2790-2015 PRODUCT 6) Custom Cardiovascular Procedure Kit X-Coated RECALL NUMBER Z-2791-2015 PRODUCT 7) Custom Cardiovascular Procedure Kit X-Coated RECALL NUMBER Z-2792-2015 CODE 1) P/N: 66041-1, Lot Number: TE06; 2) P/N: 73124, Lot Numbers: TD02,TD02A, TD23,

TD23A; 3) P/N: 7928-03, Lot Numbers: TD02, TD16; 4) P/N: 74039-02, Lot Numbers: TD02; 5) P/N: 74077-01, Lot Numbers: TD23; 6) P/N: 75185, Lot Number: TD02; 7) P/N: 75529, Lot Number: TC23

MANUFACTURED & RECALLED BY Terumo Cardiovascular Systems Corp, Ashland, MA QUANTITY 1) 5 kits, 2) 32 kits, 3) 30 kits, 4) 6 kits, 5) 15 kits, 6) 19 kits, 7) 17 kits DISTRIBUTION CA, CT, FL, WI REASON Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700

High Performance Hemoconcentrators. ------------------------------------------------------------------------------------------------------------------------------------------------ PRODUCT Radiation Therapy Treatment Planning System Software RECALL NUMBER Z-2785-2015 CODE Software build numbers 4.7.0.15 or 4.7.1.10 MANUFACTURED & RECALLED BY Raysearch Laboratories AB, Stockholm, Sweden QUANTITY 20 devices DISTRIBUTION WA REASON An error caused by a floating point precision problem tends to cause a problem with the

display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images.

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PRODUCT Bactroban Nasal Ointment and Cream RECALL NUMBER Update to prior notice CODE NDC 0029-1526-11, lot number C720096; NDC 0029-1527-22, lot numbers C707837,

C718210 MANUFACTURED & RECALLED BY GlaxoSmithKline, LLC, Zebulon, NC QUANTITY Not available at publication DISTRIBUTION Nationwide REASON This is an update to recall number D-1359-2015 and D-1361-2015 posted on 9/8/15 to

include three additional lots. Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Cough Drops (menthol-cough suppressant), sugar free black cherry, OTC, distributed by

CVS Pharmacy RECALL NUMBER D-1419-2015 CODE Lot number 50122U3, 50122U1, 50122U2 MANUFACTURED & RECALLED BY Bestco, Inc, Mooresville, NC QUANTITY 25 drop bags: 149,856; 36 drop bags: 19,200 DISTRIBUTION Nationwide REASON Presence of Foreign Tablets/Capsules: presence of comingled Sugar Free Honey Lemon

cough drops. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Surgicept (ethyl alcohol 70% w/w) Waterless Surgical Hand Scrub & Healthcare Personnel

Handwash in 1150 mL bottles RECALL NUMBER D-1427-2015 CODE Lot number GBDM MANUFACTURED BY DPT Laboratories, Ltd, Brooks City-Base, TX RECALLED BY Healthpoint, Ltd, Fort Worth, TX QUANTITY 11,910 bottles DISTRIBUTION Nationwide REASON Chemical contamination: naphthalene compound identified in the product after complaints

of a petroleum odor. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res Flowstop

in Sodium Chloride 0.9%, Rx Only RECALL NUMBER D-1428-2015 CODE NDC 61553-834-48, lot number 151900249M MANUFACTURED & RECALLED BY Pharmedium Services, LLC, Lake Forest, IL QUANTITY 120 cassettes DISTRIBUTION VA, IL, PA, ID REASON Lack of Assurance of Sterility: the firm received a complaint of a sterility failure using a

non-validated sterility test on a medication cassette. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl

oz (2mL), 1 Single Use Applicator Tip per carton RECALL NUMBER D-1418-2015 CODE NDC 62144-5510-05, lot number V0415F

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MANUFACTURED & RECALLED BY Oasis Medical, Inc, Glendora, CA QUANTITY 909 cartons DISTRIBUTION FL REASON Failed pH specification. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Methocarbamol Tablets, USP 500 mg, 500 Count Bottles, Rx Only RECALL NUMBER D-1426-2015 CODE NDC 60429-118-05, lot number GS007849 MANUFACTURED BY AustarPharma LLC, Edison, NJ RECALLED BY Golden State Medical Supply Inc, Camarillo, CA QUANTITY 1,165 Bottles DISTRIBUTION GA REASON Presence of Foreign Substance: presence of hair. -----------------------------------------------------------------------------------------------------------------------------------------------