Recall archive / FDA device enforcement
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02. — FDA record Z-1970-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 13, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 222 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1970-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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). |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to FL, IL, MO, MS, NC, NE, TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 13, 2026
- Recall initiation date
- Mar 13, 2026
- Center classification date
- May 1, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.