Halyard Cardiac Catheterization Tray Kits Recalled for Connection Risk
AVID Medical is recalling Halyard CARDIAC CATH TRAY SHANDS JAX kits due to a defect in the Medline syringe rotating adaptor that may unwind during use, causing a loose or full disconnection between the syringe and manifold.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall of a medical device used in cardiac catheterization procedures. A disconnection during use poses risk of serious injury or adverse clinical outcomes, meeting the Severe threshold for Class I recalls even without reported illnesses.
Plain-English summary
AVID Medical, Inc. is recalling Halyard CARDIAC CATH TRAY SHANDS JAX kits (Model Numbers SHND401-04 and SHND401-05) due to a potential defect in the included Medline syringe rotating adaptor. The adaptor may unwind during clinical use, resulting in a loose connection or complete disconnection between the syringe and manifold.
The recalled kits were distributed in the United States to facilities in Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas. A total of 6,956 kits are affected. Specific lot numbers are identified for each model number.
Healthcare facilities and providers using these kits should cease use of the affected lots immediately. Contact AVID Medical, Inc. for replacement kits or further instructions.
The recalled product
- Product
- Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 6,956
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 (20)
- 1. Model Number: SHND401-04. UDI-DI (Kit Lot Numbers): 10809160395615 (1577749
- 1577750
- 1590780
- 1590782
- 1590783
- 1590784
- 1590785
- 1590833
- 1591141
- 1591142
- 1597561
- 1600738
- 1613343
- 1622356
- 1631890
- 1643855
- 1643856
- 1643860
- 1644853
- 1645163
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.
See all 10 products in this recall →Related recalls
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