Agency classClass IOur severity:Severe FDA (Devices)·Z-1977-2026·Announced 2026-05-13

Halyard PERC TRAY Kit Syringe Adaptor Connection Risk Recall

The Halyard PERC TRAY kit (models SLPC34-01 and SLPC34-02) is being recalled due to risk that a Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls are never scored below 4, making this Severe. The hazard involves disconnection of a critical syringe-to-manifold connection during medical use, which poses direct risk of harm.

Plain-English summary

The Halyard PERC TRAY kit, including Model Numbers SLPC34-01 and SLPC34-02, is being recalled. The kit contains a Medline syringe rotating adaptor that poses a potential safety risk.

During use, the syringe rotating adaptor may unwind, which could result in a loose connection or complete disconnection between the syringe and manifold. This disconnection could compromise the intended function of the device.

Approximately 6,052 kits have been distributed in the United States to hospitals and medical facilities in Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas. Specific lot numbers and UDI-DI identifiers are available for both model numbers to help identify affected units.

Customers who have received this product should verify the lot number and model number against the recall information. Users should contact AVID Medical, Inc., the recalling manufacturer, for instructions on replacement or return of affected kits.

The recalled product

Product: Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Manufacturer: AVID Medical, Inc.
Category: Medical Device — Percutaneous Coronary Intervention Kit
Hazard: device-disconnection
adapter-failure
Affected units: 6,052

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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
1668810
1668812
1668813
1668814
1668815
1668816).

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 10 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Same manufacturer · AVID Medical, Inc.

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Same hazard · device disconnection