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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- 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
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.
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