AVID Medical, Inc. — Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
⚠️ Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Is this relevant to me?
- Geography
- US, FL, IL, MO, MS, NC, NE, TX
- Source agency
- FDA
- Category
- Health
- Published
- March 13, 2026
US distribution to FL, IL, MO, MS, NC, NE, TX.
What's affected?
- Product
- Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
- Brand
- AVID Medical, Inc.
- Lot code
- ):
Additional details
1. Model Number: SHND401-04. UDI-DI (Kit Lot Numbers): 10809160395615 (1577749, 1577750, 1590780, 1590782, 1590783, 1590784, 1590785, 1590833, 1591141, 1591142, 1597561, 1600738, 1613343, 1622356, 1631890, 1643855, 1643856, 1643860, 1644853, 1645163, 1647458, 1647459, 1647460, 1650983, 1652365, 1652366). 2. Model Number: SHND401-05. UDI-DI (Kit Lot Numbers): 10809160491294 (1652367, 1668844, 1668845, 1668846, 1669188, 1669189, 1669504, 1669506, 1669507, 1671312, 1671313, 1671314, 1671315, 1671316).
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 6,956 kits.
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