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.
FDA Recall Z-0604-2014 · Posted 2013-12-28
Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeFRC
Date Initiated2013-11-26
Date Terminated2014-03-05
Product Quantity4048 units total (4014 units in US)
Reason for Recall
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.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.