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 049 01 17 000
Date submitted:	1/15/2017

Manufacturer:	Molnlycke Health Care AB.
Device Type:	ProcedurePak® trays containing "Swab Gauze XRD 30x30 18ply
Description:	Swab Gauze
Medical Device Identifier:	Component code: 2317414-00
Reason of Field Safety Corrective Action:	An issue has been brought to the attention of Synergy Health (UK) Ltd from the field regarding the detachments of the tape intended to be securely stitched to the corner of "Swab Gauze XRD 30x30 18ply". The root cause has been determined to be components within the final product were past their expiry.
Remedy Action:	1.Please use the attached list to identify and isolate all affected, unused ProcedurePak® trays at your facility. 2.Please complete the attached Confirmation form and e-mail/fax back per its instructions. Even if you no longer have any concerned ProcedurePak® trays. Molnlycke Health Care needs to be sure that all customers are aware of the situation. 3.Molnlycke Health Care will contact you and arrange for collection of the product(s) from your facility, as soon as you return the confirmation form. You will be issued with a credit note for the goods returned.
Athorized Representative/Importer/Distributor:	Branch of Molnlycke Health Care AB
Report Source:	NCMDR
Source Ref. Number:	C8420534CA20D
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Molnlycke Health Care AB.pdf

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