Recalling firm
AVID Medical, Inc.
Product type
Device
Status
Ongoing
Report date
2026-05-13
Distribution
US distribution to FL, IL, MO, MS, NC, NE, TX.
Firm state
VA
Product quantity
222 kits
Initiated by
Voluntary: Firm initiated
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.
Product description
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Code / lot 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).
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.