Halyard Cardiac Cath Pack Kit Syringe Adapter Unwinding Risk
AVID Medical recalls Halyard Cardiac Cath Pack kits (Models EAMC1000-05, WAFB208-02) due to risk that a Medline syringe rotating adapter may unwind during use, causing loose or full disconnection between the syringe and manifold.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as Class I, which per the rubric mandates a minimum severity score of 4. The potential for disconnection of a critical cardiac catheterization component during medical use poses significant risk of harm, meeting the Severe threshold.
Plain-English summary
AVID Medical, Inc. is recalling Halyard Cardiac Cath Pack kits (Model Numbers EAMC1000-05 and WAFB208-02) due to a potential risk that a Medline syringe rotating adapter may unwind during use.
If the adapter unwinds, a loose connection or complete disconnection may occur between the syringe and manifold. This disconnection could compromise the integrity of the medical procedure.
The recall affects 222 kits distributed to medical facilities in Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas. Affected lot numbers include: Model EAMC1000-05 (lots 1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159) and Model WAFB208-02 (lots 1615954, 1653009).
Healthcare providers and medical facilities using these kits should cease use immediately and contact AVID Medical, Inc. for guidance on replacement or proper handling of affected units.
The recalled product
- Product
- Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 222
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 1. Model Number: EAMC1000-05. UDI-DI (Kit Lot Numbers): 10809160377314 (1573593
- 1583827
- 1609541
- 1609725
- 1612134
- 1612516
- 1619132
- 1623384
- 1627013
- 1635459
- 1672306
- 1653009).
Distribution
Part of a larger recall action
This product is one of 10 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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