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.
Hazard
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.
What You Should Do
Remedy
A customer notification letter was sent to all customers on 11/26/2013 who purchased the STERRAD CYCLESURE Biological Indicator (BI). The letter informs the customer of the problems identified and the actions to be taken. The customer notification letter includes a table with the products on recall which includes the manufacturing dates, lot numbers, expiration dates, and quantity.
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Products
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.