Recall Z-2100-2012 ยท FRC Indicator, Biological Sterilization Process
Advanced Sterilization Products
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.
| Date | Jul 27, 2012 (initiated Jun 28, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Incorrect or no expiration date |
| Action | ASP has posted the STERRAD CYCLESURE Biological Indicator customer letter on their external facing website at: wwww.aspjj.com/us/news/cyclesureletter on July 3, 2012. The letter informed customers who purchased STERRAD CYCLESURE 24 Biological Indicator (BI) product that Advanced Sterilization Products (ASP) is recalling certain lots because ASP has determined that it does not have adequate data to support the entire duration of the product's labeled shelf-life. The letter also provided the customers with what actions are needed for the recall. Customers were instructed to return all unused |
| Quantity | 38,693 units |
| Distribution | Worldwide Distribution - USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103222 | STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products, Feb 25, 2011 |