Amanta Registered & Corporate Office: Amanta Healthcare Ltd. (Formerly, Marek Biosciences Ltd.) 5th Floor, Heritage, Nr. Gujarat Vidhyapith, Ashram Road, Ahmedabad-380014, Gujarat. INDIA. Tel.: +91-79-30017500 Fax: +91-79-30017600 Ematl: [email protected]Website: www.amanta.co.in GIN: U24139GJ1994PLC023944 Amanta Healthcare Limited, Kheda. URGENT - FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION Notification and Modification to Labelling Page No. : 1 of 4 Date: 20/08/2015 Commercial Name of Affected Product Emergency Sterile Eye Wash (Sodium chloride 0.9% w/v Ph .Eur) FSN Number FSN/NS/15/004 Date of Notification 20 1 h, August 2015 Type of Action Notification and Modification to Labelling Contents Details on Affected Device Sodium chloride 0.9% w/v Ph .Eur To, Medikit Limited, Unit 1 Newporte Business Park Bishops Road, Lincoln, Lincolnshire LN24SY, UK Description of Problem : Name and Address of Manufacturer is not available on Label. Impact on Patient Safety and Device Efficacy : There is no impact on Quality, Safety and Efficacy of the Device. All essential information are available on Label/ Carton :The details are, Lot No ., Use by Date. Informat io n for use : The details describe for the usage of medical device as well warning and precauti on s. Indicates a Medical Device that is intended for one use, or for use on a single patient duri ng a single procedure. All above given information on the Label and Carton ensure the safe and efficaci ou s use of device. There is no impact on Patient Safety. Format No. : CG1 001 /F01 -00 Factory: 876, N.H. No . 8, Hariyala, Kheda-387411, GuJarat, INDIA. Tel.: +91-2694-30400 Fax: +91-2694-304050
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Amanta - moph Devices/Medical Devices... · Amanta Healthcare Limited, Kheda. URGENT -FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION Notification and Modification to Labelling Page
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