FDA DevicesClass I
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Published: May 13, 2026Recall ID: Z-1976-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Additional Source Details
| Field | Value |
|---|---|
| City | Toano |
| State | VA |
| Event id | 98686 |
| Address 1 | 9000 Westmont Dr |
| 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). |
| Postal code | 23168-9351 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 204 kits |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260313 |
| Initial firm notification | |
| Center classification date | 20260501 |
Overview
- Recalling FirmAVID Medical, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionUS distribution to FL, IL, MO, MS, NC, NE, TX.