FDA DevicesClass I
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Published: May 13, 2026Recall ID: Z-1970-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Additional Source Details
| Field | Value |
|---|---|
| City | Toano |
| State | VA |
| Event id | 98686 |
| Address 1 | 9000 Westmont Dr |
| 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). |
| Postal code | 23168-9351 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 222 kits |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260313 |
| Initial firm notification | |
| Center classification date | 20260501 |
Overview
- Recalling FirmAVID Medical, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionUS distribution to FL, IL, MO, MS, NC, NE, TX.