Recall Z-1975-2026 ยท OEZ Cardiovascular Procedure Kit
AVID Medical, Inc.
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
| Date | May 1, 2026 (initiated Mar 13, 2026) |
| Status | Open, Classified |
| Reason | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. |
| Root cause | Under Investigation by firm |
| Action | Owens and Minor/Avid Medical notified consignees on about 03/13/2026 and then sent an updated letter on about 03/18/2026 with additional kits added to the affected product list. The notice explained the issue was initiated by Medline Industries, risk associated with syringe disconnection and loose connection, and instructed consignees to identify, segregate and quarantine all affected product, and to apply warning labels to affected AVID kits to ensure all users are aware of the actions requested by Medline. This label should be applied in a prominently visible location to end-users. The locat |
| Quantity | 2,932 kits |
| Distribution | US distribution to FL, IL, MO, MS, NC, NE, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.