Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is intended to be
FDA device recall Z-0066-2010 · posted 2009-10-20 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRC
- Distribution
- Worldwide Distribution.
- Date initiated
- 2009-06-23
- Date posted
- 2009-10-20
- Date terminated
- 2011-11-29
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERRAD CYCLESURE BIOLOGICAL INDICATOR (K031226) | Advanced Sterilization Products | 2003-05-02 |
| STERRAD CYCLESURE BIOLOGICAL INDICATOR (K994055) | Advanced Sterilization Products | 2002-02-13 |