SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 059 07 15 000
Date submitted:	7/30/2015

Manufacturer:	Molnlycke Health Care AB
Device Type:	ProcedurePak trays
Description:	Dressings / Pads - others
Medical Device Identifier:	ProcedurePak® trays have been delivered with a different catheter size (19G instead of 20G).
Reason of Field Safety Corrective Action:	Mölnlycke Health Care has identified that some ProcedurePak® trays have been delivered with a different catheter size (19G instead of 20G).The resulting impact has been assessed some resistance when inserting the associated needle into incorrect catheter size and a potential issue when needle is being removed from catheter post procedure.
Remedy Action:	Please identify and isolate all affected unused product at your facility. Please affix a copy of this advisory notice to each tray and make sure that its contents are brought to the attention of all relevant personnel.
Athorized Representative/Importer/Distributor:	FAROUK, MAAMOUN TAMER & COMPANY
Report Source:	NCMDR
Source Ref. Number:	C0A089F58035E
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Molnlycke Health Care.pdf

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