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Recall Observatory FDA recall evidence

Device product

Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.

Z-1976-2026

March 13, 2026

Class I

Product summary

Firm
AVID Medical, Inc.
Event
Event 98686
Status
Ongoing
Classification
Class I
Quantity
204 kits
Official record key
device-enforcement:Z-1976-2026

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: UINR44-01. UDI (Kit Lot Number): (01)20809160484439(17)280201(10)340135(30)004(241)UINR44-01 (340135), (01)20809160484439(17)280201(10)340136(30)004(241)UINR44-01 (340136), (01)20809160454439(17)280201(10)340352(30)004(241)UINR44-01 (340352), (01)20809160484439(17)280201(10)349076(30)004(241)UINR44-01 (349076).

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.