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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 087 07 12 000
Date submitted: 7/23/2012
Manufacturer:Advanced Sterilization Products
Device Type:STERRAD CycleSure 24 Biological Indicator
Description:Biological Indicator
Medical Device Identifier: ASP03 REF 14324 Affected lot numbers: all lots manufactured since December 2011, beginning lot 339117.(see attached)
Reason of Field Safety Corrective Action: ASP recently determined that it does not have adequate data to support the entire duration of the product’s labeled shelf-life
Remedy Action: PAll customers should discontinue the use of product from lots of STERRAD® CYCLESURE® 24 Biological Indicators (BIs) that exceed the newly determined expiration date and return the affected product(s). Use of expired product may result in not being able to verify proper sterilization conditions. ASP highly recommends that your facility manually re-label the non-expired product cases with the newly calculated expiration date so that your inventory is correctly labeled for your use.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (01) 4142200
Report Source:NCMDR
Source Ref. Number:2EABDFCFF437B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Advanced Sterilization Products.pdf