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AVID Medical, Inc.: Halyard CATH LAB kit. Model Number: SACL75AM.

Medical DevicesSource: FDA (device) · Date: 2026-05-13

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
AVID Medical, Inc.
Product
Halyard CATH LAB kit. Model Number: SACL75AM.
Reason / hazard
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Classification
Class I
Status
Ongoing
Distribution / sold at
US distribution to FL, IL, MO, MS, NC, NE, TX.
Recall initiated
2026-03-13
Code info
Model Number: SACL75AM. UDI-DI (Kit Lot Numbers): 10809160413586 (1599684, 1601393).
Product quantity
228 kits
Voluntary mandated
Voluntary: Firm initiated
City
Toano
State
VA
Country
United States
Event id
98686
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