AVID Medical, Inc.: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- AVID Medical, Inc.
- Product
- Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
- Reason / hazard
- 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of NC and TX.
- Recall initiated
- 2026-04-30
- Code info
- UDI-DI 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932
- Product quantity
- 5168 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Toano
- State
- VA
- Country
- United States
- Event id
- 99339
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