AVID Medical, Inc.: Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

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.

Details from the source

Reason for recall: 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. Distribution: US distribution to FL, IL, MO, MS, NC, NE, TX. Quantity: 222 kits Lot/code info: 1. Model Number: EAMC1000-05. UDI-DI (Kit Lot Numbers): 10809160377314 (1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159). 2. Model Number: WAFB208-02. UDI-DI (Kit Lot Numbers): 10809160424759 (1615954, 1653009).

UPC codes

10809160377314, 10809160424759

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.