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Recall Observatory FDA recall evidence

Device product

Halyard CATH LAB kit. Model Number: SACL75-01.

Z-1974-2026

March 13, 2026

Class I

Product summary

Firm
AVID Medical, Inc.
Event
Event 98686
Status
Ongoing
Classification
Class I
Quantity
172 kits
Official record key
device-enforcement:Z-1974-2026

Official wording

Reason: 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.

Code information: 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).

Distribution pattern: US distribution to FL, IL, MO, MS, NC, NE, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.