Z-2797-2026 Class I Ongoing
FDA device recall Z-2797-2026 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. SAMMC ANGIOGRAPHY SAMM066-15
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 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932