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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 111 10 14 000
Date submitted: 10/27/2014
Manufacturer:Kimal plc
Device Type:Kimal Procedure Pack containing High Pressure Manifold
Description:Surgical Instrument Procedure Pack
Medical Device Identifier:Product code : ES-K37036
Batch / Lot number affected : 14F0193
Reason of Field Safety Corrective Action:The manufacturer has issued a Field Safety Notice regarding Kimal procedure packs containing a manifold 2 Port High Pressure Right Port Off. Kimal plc has identified that the specified procedure pack below contains a normal pressure manifold, rather than the above mentioned high pressure manifold.
Remedy Action:The manufacturer will arrange free of charge replacement products meeting the correct specification
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCAR
Source Ref. Number:UK-2014-10-03-187
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: fsn.pdf