Halyard CATH LAB Kit Recalled for Syringe Adapter Disconnection Risk
AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75AM) because the syringe rotating adapter 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. The hazard (disconnection of a catheter lab syringe-manifold connection during use) presents serious risk of harm in a clinical setting. Although no reported illnesses or injuries are stated in the source text, FDA Class I recalls are inherently scored at 4 or higher per the rubric.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard CATH LAB kit, Model Number SACL75AM. The product contains a Medline syringe rotating adapter that may unwind during use, potentially resulting in a loose connection or complete disconnection between the syringe and the manifold.
A total of 228 kits have been distributed in the United States to facilities in Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas. The affected kits are identified by UDI-DI (Kit Lot Numbers): 10809160413586 (Lot Numbers 1599684 and 1601393).
Patients and healthcare facilities using this product should inspect the syringe rotating adapter connection for proper engagement and monitor for any signs of disconnection during use. Contact AVID Medical, Inc. for further instructions regarding the recalled kits.
The recalled product
- Product
- Halyard CATH LAB kit. Model Number: SACL75AM.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 228
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 (2)
- Model Number: SACL75AM. UDI-DI (Kit Lot Numbers): 10809160413586 (1599684
- 1601393).
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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