STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monito
FDA device recall Z-0604-2014 · posted 2013-12-28 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRC
- Quantity affected
- 4048 units total (4014 units in US)
- Distribution
- Worldwide Distribution.
- Date initiated
- 2013-11-26
- Date posted
- 2013-12-28
- Date terminated
- 2014-03-05
- 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 |