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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 011 08 11 000
Date submitted: 8/7/2011
Manufacturer:Coloplast A/S
Device Type:Open-ended intestinal ostomy bag, one-piece, Sensura post-op sterile, Sensura 1pc drainable sterile, Assura/Alterna post-op sterile
Description:Open-ended intestinal ostomy bag, one-piece
Medical Device Identifier:N/A
Reason of Field Safety Corrective Action:One lot of sensura sterile post-operative ostomy bag and assura sterile post-operative ostomy failed during routine product test of sterility.
Remedy Action:The manufacturer is recalling the affected lots.
Athorized Representative/Importer/Distributor:Al Hammad Medical Services, Riyadh, (01) 4655610
Report Source:NCAR
Source Ref. Number:DK-2011-08-05 - 007
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments