Recall Z-0066-2010 ยท FRC Indicator, Biological Sterilization Process
Advanced Sterilization Products
Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles.
| Date | Oct 20, 2009 (initiated Jun 23, 2009) |
| Status | Terminated |
| Reason | Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time. |
| Root cause | Device Design |
| Action | An Important Product Labeling Correction - New Instructions for Use dated, June 26, 2009, has been proposed to be sent by the firm for Cyclosure Biological Indicators to consignees. The revised instructions reduce the maximum read time for the indicators to 3 days (72 hours). The letter also states why ASP changed the Instructions. Questions are to be directed to ASP Customer Care Center. |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |