Z-2798-2026 Class I Ongoing
FDA device recall Z-2798-2026 was initiated by AVID Medical, Inc. on April 30, 2026 and is designated Class I. Reason for recall: 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 with… The recall status is ongoing. Affected quantity: 5168 kits.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- April 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5168 kits
Product Description
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of NC and TX.
Code Information
UDI-DI 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950