Reported Aug 8, 2012 · Terminated
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation…
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), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
- Lot codes and dates
161 of 161 codes
Lot# 002127003127005127006127007127008127009127010127011128012127013127014127015127016127018127019127020127021127023127024127025127026127027127028127030127031127032127033127034127035127036127037127038121038127 039127040127041121042127043127044127045121045127046127047127048127049127052127053121053127054127055121056127057127058127059127060127061127062121062127063127064127
- Amount recalled
- 38,693 units
Where it was sold
- Nationwide
Why it was recalled
Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
This product could cause temporary or reversible health problems — stop using it.
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