Z-2796-2026 Class I Ongoing
FDA device recall Z-2796-2026 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. CARDIAC CATH PACK EAMC1000-05
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 10809160377314 Lots 1573593 1583827 1609541 1612134 1612516 1619132 1623384 1627013 1635459 1672306 1675159