STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products
FDA device recall Z-0520-2013 · posted 2012-12-12 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life.
- Action taken
- Advanced Sterilization Products (ASP) sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated November 2, 2012 to all customers who received the Sterrad Cyclesure 24 Biological Indicator (BI) product P/N 14324 manufactured between February 2008 and December 2011. The letter informed the customers of the problem identified and the actions to be taken. ASP determined that the 24 BI may not have adequate data to support the entire duration of the labeled shelf life of affected product manufactured during the above timeframe. The letter also informed customers that this is a different recall from the previous July 3, 2012 STERRAD CYCLESURE 24 BI recall. Customers with questions or need additional packing labels are instructed to call Stericycle at (877) 650-7692.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRC
- Quantity affected
- 38,532 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of AR, AU, BE, BR, CA, CL, CN, CO, EC, GT, HK, ID, IN, JP, KR, MX, MY, PA, PE, PH, SG, TH, VE, and RU.
- Date initiated
- 2012-10-03
- Date posted
- 2012-12-12
- Date terminated
- 2013-07-19
- 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 (K103222) | Advanced Sterilization Products | 2011-02-25 |