Class I U.S. Food and Drug Administration

AVID Medical, Inc. Halyard Perc Tray kit. Model Numbers: Slpc34-01, Slpc34-02 recall: Potential risk for Medline syringe rotating adaptor unwinding during use

Recall published 6 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1977-2026
Published
May 13, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
AVID Medical, Inc.
Product type
Medical devices
Units affected
6,052 kits
Distribution
Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, Texas
Made in
United States
Lot / 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).
UPC codes
10809160450963, 10809160459904, 108916049515, 10809160511213

Products covered by this recall

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

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10809160450963
  • 10809160459904
  • 108916049515
  • 10809160511213

Model or item number

On the rating label, the box or the instruction sheet.

  • SLPC34-01
  • SLPC34-02. UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

AVID Medical, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: AVID Medical, Inc. — 9000 Westmont Dr, Toano, VA, 23168-9351

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was AVID Medical, Inc. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10809160450963, 10809160459904, 108916049515; model number SLPC34-01, SLPC34-02. UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Which states were affected?

The notice lists Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, Texas.

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