AVID Medical, Inc.: Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
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 CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
- Reason / hazard
- 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US distribution to FL, IL, MO, MS, NC, NE, TX.
- Recall initiated
- 2026-03-13
- Code info
- 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).
- Product quantity
- 6,956 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Toano
- State
- VA
- Country
- United States
- Event id
- 98686
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