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.
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: 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.
- Hazard
- connection-failure
- equipment-malfunction
- adapter-unwinding
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
Distributed in 7 states:
- FL
- IL
- MO
- MS
- NC
- NE
- TX