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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 026 05 15 001
Date submitted: 6/3/2015
Manufacturer:Kimal plc
Device Type:Devon Light Glove included in various Kimal Procedure Packs
Description:This product is a disposable cover used in operating rooms
Medical Device Identifier:Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K20380

Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K20380/P1

Product Description: KFMC PAEDIATRIC PACK Product Code: SA-K41949/P1

Product Description: KKNGH CARDIOLOGY PACING PACK Product Code: SA-K42117

Product Description: KKNGH REVEAL PACK Product Code: SA-K42118

Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K43714

Product Description: CAESARIAN-SECTION PACK PSCC Product Code: SPR/9911/45035

Product Description: KFNGH PAEDIATRIC CATH LAB PACK Product Code: SPR/9964/41494

Product Description: KFNGH ADULT CATH LAB PACK Product Code: SPR/9964/41495

Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/42508

Product Description: KKUH PAEDIATRIC ANGIO PACK Product Code: SPR/9964/42865

Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/43714

Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/45033

Lot Numbers : Please see attached


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MHRA update code
Multiple products and Lot numbers of the affected device are provided in the attached FSN.
Reason of Field Safety Corrective Action:The light glove may contain splits or holes or be torn.
Remedy Action:The manufacturer is asking end users to discard the light handle covers rather than returning affected packs to minimise the disruption to scheduled procedures. Kimal will provide free of charge light handle covers to use alongside the affected procedure packs.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR, MHRA
Source Ref. Number:B09C8F2B4F255, 2015/004/029/601/015
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Kimal-update codes.pdf