Recall Z-2798-2026 ยท OEZ Cardiovascular Procedure Kit
AVID Medical, Inc.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
| Date | Jul 31, 2026 (initiated Apr 30, 2026) |
| Status | Open, Classified |
| Reason | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels. |
| Root cause | Under Investigation by firm |
| Action | On April 30, 2026, firm notified distributors via email. Distributors were tasked with notifying their end-users. Customers were instructed to identify, segregate, and quarantine all impacted products. They were provided with a labeling template to print warning labels which should be affixed on all affected kits and cases in inventory. The firm is also able to provide pre-printed labels if needed. Warning labels inform users to remove and discard the manifold prior to use. |
| Quantity | 5168 kits |
| Distribution | US Nationwide distribution in the states of NC and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.