Recall Z-1455-2016 ยท OFA Cardiovascular Surgical Instruments Tray
Customed, Inc
Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
| Date | Apr 14, 2016 (initiated Jan 7, 2016) |
| Status | Terminated |
| Reason | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| Root cause | Packaging |
| Action | Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016. |
| Quantity | 47 |
| Distribution | Distributed only in Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904693 | CUSTOMED CARDIOVASCULAR PACK Customed, Inc., Jan 2, 1991 |