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

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

Read the official notice at FDA (device) →

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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 NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
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: 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).
Product quantity
204 kits
Voluntary mandated
Voluntary: Firm initiated
City
Toano
State
VA
Country
United States
Event id
98686
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