SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 032 07 13 000
Date submitted:	7/3/2013

Manufacturer:	PAUL HARTMANN
Device Type:	Folio dress gown Comfort Basic
Description:	sterile, Single-use
Medical Device Identifier:	See attached
Reason of Field Safety Corrective Action:	A quality inspection revealed the individual occurrence of micro-holes in a number of blisters (sterile packaging) containing terile surgical gowns and isolation gowns. The micro-holes are unlikely to be detected through visual inspection. As a result, the sterility of affected products may be compromised.
Remedy Action:	Please examine your inventory and do not use the affected products any longer and return product
Athorized Representative/Importer/Distributor:	ABDULREHMAN AL GOSAIBI GTB, Riyadh, (011) 4771374
Report Source:	NCMDR
Source Ref. Number:	FCCA25EF2D307
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments:	PAUL.pdf

View History