Z-1976-2026Class I

AVID Medical, Inc.

Recalling firm

AVID Medical, Inc.

Product type

Device

Status

Ongoing

Report date

2026-05-13

Distribution

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

Firm state

Product quantity

204 kits

Initiated by

Voluntary: Firm initiated

Reason for recall

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.

Product description

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

Code / lot 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).

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.