AVID Medical, Inc. — Halyard CATH LAB kit. Model Number: SACL75-01.
⚠️ 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.
Is this relevant to me?
- Geography
- US, FL, IL, MO, MS, NC, NE, TX
- Source agency
- FDA
- Category
- Health
- Published
- March 13, 2026
US distribution to FL, IL, MO, MS, NC, NE, TX.
What's affected?
- Product
- Halyard CATH LAB kit. Model Number: SACL75-01.
- Brand
- AVID Medical, Inc.
- Lot code
- ):
Additional details
Model Number: SACL75-01. UDI (Kit Lot Numbers): (01)20809160481377(17)280520(10)341730(30)004(241)UINR44-01 (341730), (01)20809160481377(17)280623(10)341742(30)004(241)SACL75-01 (341742), (01)20809160481377(17)280609(10)345855(30)004(241)SACL75-01 (345855), (01)20809160481377(17)280609(10)345863(30)004(241)SACL75-01 (345863).
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 172 kits.
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