Halyard VA Detroit Cath Lab Pack Kit Syringe Adaptor Disconnection Risk
Halyard VA Detroit Cath Lab Pack kits (Model VMCD029) are being recalled due to a potential risk that the Medline syringe rotating adaptor 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 agency has classified this as FDA Class I, which per the rubric requires a minimum severity score of 4. The potential for disconnection of a syringe from a manifold during catheterization procedures presents a significant risk of harm in a critical clinical setting.
Plain-English summary
Halyard VA Detroit Cath Lab Pack kits (Model Number VMCD029) manufactured by AVID Medical, Inc. are being recalled. The Medline syringe rotating adaptor included in these kits may unwind during use, which could result in a loose connection or complete disconnection between the syringe and manifold.
The affected kits have UDI-DI lot numbers 10809160388969 with lot numbers 1601753, 1601754, and 1621560. These kits were distributed in the United States to FL, IL, MO, MS, NC, NE, and TX. A total of 75 kits are subject to this recall.
Healthcare facilities and providers who have received these kits should stop using them immediately and contact AVID Medical, Inc. for instructions on return or replacement. Any adverse events or injuries related to this product should be reported to FDA MedWatch.
The recalled product
- Product
- Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 75
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 (3)
- Model Number: VMCD029. UDI-DI (Kit Lot Numbers): 10809160388969 (1601753
- 1601754
- 1621560).
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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