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AVID Medical, Inc.: Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.

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 PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
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
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).
Product quantity
6,052 kits
Voluntary mandated
Voluntary: Firm initiated
City
Toano
State
VA
Country
United States
Event id
98686
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