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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 035 07 12 000
Date submitted: 7/15/2012
Manufacturer:Stryker Instruments
Device Type:Instrument Trays, Arthroscope and Hardware Set Trays
Description:Instrument Trays, Sterilization Containers
Medical Device Identifier:Part No. 233-032-116 All lot
Reason of Field Safety Corrective Action:During a review and retest of the sterilization parameters, gravity steam, EO and Sterrad sterilization cycles did not consistently sterilize all of the products in the tray.
Remedy Action:Identify any affected product in your inventory. Ensure that any obsolete IFUs are discard, and find attached for new IFU.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:B27F6F86BB2E1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Autoclavable Arthroscope Hardware Tray.pdf