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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 039 05 12 000
Date submitted: 5/14/2012
Manufacturer:PAUL HARTMANN
Device Type:Sterile gauze products
Description:Sterile, Single-use
Medical Device Identifier:4512048
Reason of Field Safety Corrective Action:In a laboratory test micro-holes in a number of blisters containing sterile gauze products were detected. The micro-holes are unlikely to be detected through visual inspection. Further tests do not allow us to reliably exclude a risk of individual occurrence of micro holes in these products. 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, (01) 4771374
Report Source:NCMDR
Source Ref. Number:A589EEF705318
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: PAUL HARTMANN.pdf