FDAClass IMay 13, 2026

Halyard CARDIAC CATH PACK kit recall

Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

Why was Halyard CARDIAC CATH PACK kit recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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).

Product
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Recalling firm
AVID Medical, Inc.
Quantity
222 kits
Distribution
US distribution to FL, IL, MO, MS, NC, NE, TX.
Recall date
May 13, 2026
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls