FDAHealthMarch 13, 2026
AVID Medical, Inc. — Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
⚠️ 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 PACK kit. Model Number: EAMC1000-05, WAFB208-02.
- Brand
- AVID Medical, Inc.
- Lot code
- ):
Additional details
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).
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 222 kits.
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