AVID Medical, Inc.: Halyard CATH LAB kit. Model Number: SACL75-01.
Read the official notice at FDA (device) →
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: SACL75-01.
- 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: 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).
- Product quantity
- 172 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Toano
- State
- VA
- Country
- United States
- Event id
- 98686
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