Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
FDA device recall Z-1312-2015 · posted 2015-03-23 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.
- Action taken
- A customer notification letter was sent on 12/24/14 to all customers who purchased the expired Tyvek Rolls with STERRAD Chemical Indicator. The letter informs the customers of the problems identified and the actions to be taken.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FRG
- Quantity affected
- 2 units
- Distribution
- Saudi Arabia and Portugal
- Date initiated
- 2014-12-24
- Date posted
- 2015-03-23
- Date terminated
- 2015-09-04
- 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 |
|---|---|---|
| Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (K141693) | Advanced Sterilization Products | 2014-12-19 |