STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperat
FDA device recall Z-0843-2015 · posted 2014-12-22 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
- Action taken
- A customer notification letter dated 11/21/2014 will be sent to all customers who purchased the STERRAD 50, STERRAD 100S, STERRAD 200, STERRAD 100NX, and STERRAD NX System Cassettes. The letter informs the customers of the problems identified and the actions to be taken.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FLF
- Quantity affected
- 19,978 units total (9,792 units in US)
- Distribution
- Worldwide Distribution.
- Date initiated
- 2014-11-04
- Date posted
- 2014-12-22
- Date terminated
- 2015-08-04
- 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 50 & STERRAD 100S STERILIZERS (K023290) | Advanced Sterilization Products | 2003-04-03 |