FDA DevicesClass I
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Published: May 13, 2026Recall ID: Z-1977-2026Category: 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 PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Additional Source Details
| Field | Value |
|---|---|
| City | Toano |
| State | VA |
| Event id | 98686 |
| Address 1 | 9000 Westmont Dr |
| Code info | 1. Model Number: SLPC34-01. UDI-DI (Kit Lot Numbers): 10809160450963 (1640169, 1641409, 1641410, 1641411, 1641412, 1641413, 1641414, 1641415, 1645684); 10809160459904 (1649576, 1660882, 1660883, 1660884, 1663896, 1665768). 2. Model Number: SLPC34-02. UDI-DI (Kit Lot Numbers): DHR 108916049515 NAV 10809160511213 (1668809, 1668810, 1668812, 1668813, 1668814, 1668815, 1668816). |
| Postal code | 23168-9351 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 6,052 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.