Reported Jan 8, 2014 · Terminated
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent…
Advanced Sterilization Products
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Sterilization Products · 33 Technology Dr · Irvine, CA · 92618-2346
Is this the product you have?
- STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
- Lot codes and dates
- Batch/Lot No.
85 of 85 codes
149137061501370615413706154131061551370615613706157137061591370616113706161131061621370616413706164138061661370616813706168138061691370617113706172137061751370617613706177137061781370617913706180137061831370618413706189137061901370619113706192137061931370619613706197137061981370619913706200137062011370620313706204137062061370620713706208137062111370621213706213137062141370621513706215138062171370621813706219137062201370622113706222137062241370622513706226137062271370622813706
- Batch/Lot No.
- Amount recalled
- 4048 units total (4014 units in US)
Why it was recalled
Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.
This product could cause temporary or reversible health problems — stop using it.
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