COMPANIES RECALLING THREE BRANDS OF HOT/COLD … packs has been reported locally, the incident in Australia prompted HSA to ... COMPANIES RECALLING THREE BRANDS OF HOT/COLD PACKS FOUND

Page 1 of 14 Copyright of Health Sciences Authority

FOR IMMEDIATE RELEASE

HEALTH SCIENCES AUTHORITY

PRESS RELEASE

20 October 2008

COMPANIES RECALLING THREE BRANDS OF HOT/COLD PACKS

FOUND TO CONTAIN TOXIC SUBSTANCE

Ten hot/cold packs marketed under three brands sold in Singapore have been voluntarily recalled by their companies after laboratory tests revealed that they contained a toxic anti-freeze ingredient, ethylene glycol. It is estimated that a total of about 2,000 pieces of the affected products have been sold to consumers. There are no reported cases of adverse reactions or illnesses arising from the use of hot/cold packs in Singapore. Affected Brands and Products 2 Hot/cold packs are low-risk medical devices used as an external compress to relieve headache, toothache, aching muscles and strains. The products can be frozen for cold therapy or heated for heat therapy and applied to the area where the pain is. They can also be used as masks for the eyes and face, as well as cold therapy for relief of fever discomfort in children and adults. These packs should contain a non-toxic substance, propylene glycol, as the anti-freeze ingredient instead of ethylene glycol, which is toxic. 3 The affected ten hot/cold packs marketed under three brands being recalled are: Product Code

Brand Product Description

6230 SURGIPACK® Soft Hot/Cold Pack Large

One rectangular piece of blue Nylon coated PVC bag containing gel-like substances

6231 SURGIPACK® Soft Hot/Cold Pack Small


SP-7201 Soft R&R Cold/Hot Pack - M


SP-7203 Soft R&R Cold/Hot Pack - L

One rectangular piece of blue Nylon/PVC bag containing gel-like substances

OS-1260 OSIM uBaby Fever Band One rectangular piece of blue plastic pack


containing a colourless gel-like substance OS-1261 OSIM Shoulder Pad One irregularly-shaped piece of blue

plastic pack containing a colourless gel-like substance,

OS-1263 OSIM uKids Fever Band One rectangular piece of blue plastic pack containing a colourless gel-like substance

OS-1264 OSIM Face Mask One face-shaped piece of blue plastic pack containing a colourless gel-like substance

OS-1265 OSIM Eye Mask One spectacle-shaped piece of blue plastic pack containing a colourless gel-like substance

OS-1267 OSIM Hot/Cold Compress Two kidney-shaped pieces of blue plastic packs containing colourless gel-like substances

Please refer to Annex A for photographs of the affected products. Recall Action and Information 4 The Health Sciences Authority (HSA) was first alerted to a recall of a hot/cold pack in Australia following a case of accidental poisoning in a young child who chewed through the plastic packaging of a pack and consumed its contents which contained ethylene glycol. Although no injury or illness arising from the use of hot/cold packs has been reported locally, the incident in Australia prompted HSA to investigate the hot/cold packs available in Singapore. 5 HSA conducted laboratory tests on product samples of six brands sold at major pharmacies, and found that three brands carried products containing ethylene glycol, as listed in Annex A. A list of hot/cold packs containing the non-toxic substance, propylene glycol, as the anti-freeze ingredient is found in Annex B. 6 HSA informed the companies marketing these affected products on its findings and the companies have undertaken voluntary recall of all affected products from wholesale outlets, retail shops and pharmacies from 16 Oct 2008. These companies will also be placing public announcements of their recalls of the affected products. 7 It is estimated that a total of about 2,000 pieces of the affected products have been sold to consumers. Consumers who have purchased these affected products should stop using them immediately. For further information, consumers can directly contact the respective companies dealing in the affected products.

Brand Company Consumer’s Hotline

Surgipack® Tyco Healthcare Pte Ltd. 6482 2098 Soft R & R Assisted Living Pte Ltd. 6254 2916 Soft R & R Lifeline Corporation Pte Ltd 6289 2062

OSIM OSIM International, Ltd. 6741 1538


8 HSA is looking into the circumstances leading to the recall. Presently, HSA is monitoring the recall closely and working closely with the manufacturers and dealers to ensure a successful recall. Ensuring the successful completion of the recall is HSA’s top most priority now. In the meantime, all imports, exports and sales of the affected hot/cold packs have been stopped with immediate effect. HSA’s Consumer Advisory 9 Although no illness arising from the use of hot/cold packs has been reported to date, this recall has been undertaken to protect consumers from the possible risks when using the affected packs. In normal usage, there should be no danger of ingestion or contact with the skin. However, there may be instances where the package may rupture (e.g. due to wear and tear) leading to accidental ingestion or contact with the skin. Ethylene glycol is harmful or fatal if swallowed, and can cause serious effects if inhaled or absorbed through skin. It may also cause allergic skin reactions. 10 HSA would like to advise parents to ensure that all gel-containing hot/cold packs are to be used under adult supervision. In the event of accidental ingestion, consumers should seek immediate medical attention. 11 HSA will update the public when more information becomes available. Interested members of the public can refer to the list of Frequently Asked Questions in Annex C for more consumer-related information.

HEALTH SCIENCES AUTHORITY 20 OCT 2008

About the Health Sciences Authority

The Health Sciences Authority (HSA) applies medical, pharmaceutical and scientific expertise through its three professional groups, Health Products Regulation, Blood Services, Applied Sciences, to protect and advance national health and safety. HSA is a multidisciplinary authority. It serves as the national regulator for health products, ensuring they are wisely regulated to meet standards of safety, quality and efficacy. It operates the national blood bank, Bloodbank@HSA, securing the nation’s blood supply. It also applies specialised scientific, forensic, investigative and analytical capabilities in serving the administration of justice. For more details, visit www.hsa.gov.sg.


ANNEX A PRESS RELEASE: COMPANIES RECALLING THREE BRANDS OF HOT/COLD PACKS FOUND TO CONTAIN TOXIC SUBSTANCE

LIST OF HOT/COLD PACKS RECALLED

Pdt Code


Photograph

6230 SURGIPACK® Soft Hot/Cold Pack Large


6231 SURGIPACK® Soft Hot/Cold Pack Small


SP-7201

Soft R&R Cold/Hot Pack - M



SP-7203

Soft R&R Cold/Hot Gel Pack - L

One rectangular piece of blue Nylon/PVC bag containing gel-like substances

OS-1260

OSIM uBaby Fever Band

One rectangular piece of blue plastic pack containing a colourless gel-like substance

OS-1261

OSIM Shoulder Pad

One irregularly-shaped piece of blue plastic pack containing a colourless gel-like substance,


OS-1263

OSIM uKids Fever Band

One rectangular piece of blue plastic pack containing a colourless gel-like substance

OS-1264

OSIM Face Mask

One face-shaped piece of blue plastic pack containing a colourless gel-like substance


OS-1265

OSIM Eye Mask

One spectacle-shaped piece of blue plastic pack containing a colourless gel-like substance

OS-1267

OSIM Hot/Cold Compress

Two kidney-shaped pieces of blue plastic packs containing colourless gel-like substances


ANNEX B PRESS RELEASE: COMPANIES RECALLING THREE BRANDS OF HOT/COLD PACKS FOUND TO CONTAIN TOXIC SUBSTANCE

LIST OF HOT/COLD PACKS NOT AFFECTED BY RECALL

(SAMPLES TESTED; FOUND NOT TO CONTAIN ETHYLENE GLYCOL)

Pdt Code


Photograph

1570 3M Nexcare™ First Aid Reusable ColdHot Pack

Two rectangular pieces of transparent plastic packs containing a blue gel-like substance

HC-35006

Compad Medi-Gel™ Hot Cold Pack

One rectangular piece of transparent plastic pack containing a blue gel-like substance


OS-1262

OSIM Instant Heat Pad

Metal disc on surface of the heat pack. When pressure is applied to the metal disc, the colourless gel-like substance turns into hot solid crystals.

OS-1266

OSIM Instant Heat Compress

One kidney-shaped piece of blue plastic pack containing a colourless gel-like substance


- Medi-Ice Pak Medi-Pak Reusable Hot/Cold Pack


MH-74912

Tyco Healthcare Uni-Patch Versa-Pac® Reusable Hot and Cold Pack



HP-806

OTO Bodycare Heat Pack

Metal disc on surface of the heat pack. When pressure is applied to the metal disc, the colourless gel-like substance turns into hot solid crystals.


ANNEX C PRESS RELEASE: COMPANIES RECALLING THREE BRANDS OF HOT/COLD PACKS FOUND TO CONTAIN TOXIC SUBSTANCE FREQUENTLY ASKED QUESTIONS Q1 What are hot/cold packs and what are they for? Hot/cold packs are low-risk medical devices used as an external compress to relieve headache, toothache, aching muscles and strains. The products can be frozen for cold therapy or heated in a microwave for heat therapy and applied to the area where the pain is. They can also be used as masks for the eyes and face, as well as cold therapy for relief of fever discomfort in children and adults. Q2 Why is there a need for a recall to be conducted on some brands of hot/cold packs? Hot/cold packs usually contain the non-toxic substance, propylene glycol, as the anti-freeze ingredient. However, HSA detected toxic ethylene glycol, instead of propylene glycol, in the content of some hot/cold packs. Ethylene glycol is harmful or fatal if swallowed, and can cause serious effects if inhaled or absorbed through skin. Ethylene glycol may also cause allergic skin reactions. The affected hot/cold packs which contain ethylene glycol have already been removed from the wholesale and retail market. This public notification is intended to inform consumers who have already bought the affected products. Q3 What are the signs/symptoms of ethylene glycol poisoning if one consumes the contents in the affected hot/cold pack? Initial symptoms from ingesting ethylene glycol maybe include drowsiness, nausea and vomiting. In the case of accidental ingestion, consumers should seek immediate medical attention at the nearest emergency department. Q4 I have been using the affected hot/cold pack for a while. Although I did not consume the contents, will I suffer any long term side effects? These products are generally safe when used as intended as an external hot/cold compress, as long as you are not exposed to the contents. There should not be any long term side effects from using hot/cold pack. However, if the package shows signs of wear and tear, is mishandled or misused, it may rupture. This may lead to accidental ingestion of the gel content or contact with the skin. Please discard the pack immediately.


Q5 Who can I contact if I have medical concerns about using these products? Consumers should seek advice from registered health professionals for any medical concerns. In the case of accidental ingestion, consumers should seek immediate medical attention at the nearest emergency department. Q6 What is HSA's hotline for the public? Consumers can call HSA’s Medical Device Branch at Hotline: 6866 3560 (from 9am to 7pm, Monday to Friday). Q7 What should I do if I have an affected hot/cold pack at home? Will I get a refund, and do I need to produce a receipt for the refund? If you have an affected hot/cold pack at home, do not use it. Please contact the company that you have purchased the product from for more information. Brand Company Consumer’s Hotline

Surgipack® Tyco Healthcare Pte Ltd. 6482 2098 Soft R & R Assisted Living Pte Ltd. 6254 2916 Soft R & R Lifeline Corporation Pte Ltd 6289 2062

OSIM OSIM International, Ltd. 6741 1538 Q8 I have a hot/cold pack at home, but I have lost the packaging. I am unable to remember what the brand/model is. What should I do? When in doubt, do not use the hot/cold pack. Q9 If I would have to return the affected hot/cold pack, what are other alternatives that I can consider using? Alternatives that do not contain the toxic anti-freeze ingredient ethylene glycol, include the hot/cold packs listed in Annex B, ice pack/bags, hot water bags and instant hot packs. Q10 Must all hot/cold packs be tested and approved by HSA before they are allowed to be sold in Singapore? Hot/cold packs are currently not tested and approved by HSA before they are sold. Dealers of hot/cold packs are responsible for the safety, quality and performance of their products, and also to report adverse events and notify product recalls to HSA. To complement these mandatory duties imposed on the dealers, HSA has an active post-market surveillance programme which includes monitoring adverse reaction


reports from our hospitals and our regulatory counterparts, as well as carrying out testing of product samples. The post-market surveillance system allows HSA to take quick action to warn the public, investigate and when necessary, recall products that may be causing unexpected side effects. Q11 Are hot/cold packs still safe to use in spite the recall? These products are generally safe when used as intended as an external hot/cold compress, as long as you are not exposed to the contents. However, as these products are not intended for use as toys, their use on children should not go unsupervised.

COMPANIES RECALLING THREE BRANDS OF HOT/COLD … packs has been reported locally, the incident in Australia prompted HSA to ... COMPANIES RECALLING THREE BRANDS OF HOT/COLD PACKS FOUND

Documents