Z-1970-2026 Class I Ongoing

Recalled by AVID Medical, Inc. — Toano, VA

Recall Details

Product Type
Devices
Report Date
May 13, 2026
Initiation Date
March 13, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
222 kits

Product Description

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

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 Pattern

US distribution to FL, IL, MO, MS, NC, NE, TX.

Code Information

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).