Recall Z-1411-2016 ยท NXA Tracheotomy Care Kit
Customed, Inc
Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT 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 | 2800 |
| Distribution | Distributed only in Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925020 | TRACHEOSTOMY CARE KIT (STERILE) Customed, Inc., Jul 7, 1993 |