Recall Z-0604-2014 ยท FRC Indicator, Biological Sterilization Process
Advanced Sterilization 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.
| Date | Dec 28, 2013 (initiated Nov 26, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 4048 units total (4014 units in US) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103222 | STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products, Feb 25, 2011 |