Recall Z-1312-2015 · FRG Wrap, Sterilization
Advanced Sterilization Products
Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
| Date | Mar 23, 2015 (initiated Dec 24, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 2 units |
| Distribution | Saudi Arabia and Portugal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator Advanced Sterilization Products, Dec 19, 2014 |