Z-1970-2026Class I
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02
Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2026-03-13 / Open, Classified
AVID Medical, Inc. began a recall of Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02 on . FDA classified it as Class I and gives the reason as "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". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1970-2026
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Avid Medical, Inc. a Medical Action Ind. Company 305
- Product
- Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
- Product code
- OES Cardiac Catheterization Kit
- 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.
- FDA root cause
- Under Investigation by firm
- Action
- Owens and Minor/Avid Medical notified consignees on about 03/13/2026 and then sent an updated letter on about 03/18/2026 with additional kits added to the affected product list. The notice explained the issue was initiated by Medline Industries, risk associated with syringe disconnection and loose connection, and instructed consignees to identify, segregate and quarantine all affected product, and to apply warning labels to affected AVID kits to ensure all users are aware of the actions requested by Medline. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Per Medline, due to the risk of serious injury or death, customers are directed to remove and destroy all Namic RA Syringes. If use is unavoidable because failure to proceed would result in patient harm, the Namic RA syringe must be used with extreme caution and vigilance, including manual stabilization of syringe-to-manifold connections and continuous, 100% monitoring during setup and throughout the entire procedure. All usage guidelines and the Instructions for Use are provided in Medline s recall letter. Consignees were also instructed to complete and return the Recall Response Form as well as to notify customers if affected kits were further distributed to ensure all end-users are appropriately notified and maintain records of effectiveness.
- Quantity in commerce
- 222 kits
- Distribution
- US distribution to FL, IL, MO, MS, NC, NE, TX.
- Product codes and lots
- 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).
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1970-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1971-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1972-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1973-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1974-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1975-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1976-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1977-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1978-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1979-2026 | Class I | Ongoing | Voluntary: Firm initiated |
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