Recall Weekly
Moderate riskFDA DeviceClass II

Halyard STANDARD LINE INSERTION PACK recalled for silicone seal defects causing fluid leakage risk

Certain Halyard STANDARD LINE INSERTION PACK kits (Model PVHM234-01) have a defect in the silicone seal that may not seal properly. This defect can cause the seal to dome inward, potentially blocking fluid flow or allowing fluid to leak where it shouldn't.

From the FDA notice · Read the official notice ↗ · All AVID Medical recalls

What to do

  1. If you have lot 1597314 (expires 8/31/2026) or lot 1599022 (expires 5/31/2026), do not use the kit.
  2. Contact AVID Medical, Inc. or your healthcare facility for guidance on replacement or safe disposal.
  3. Report any problems with the product to the FDA MedWatch program.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
112 kits
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Classification
Class II
Recall number
Z-2772-2026

In the FDA's words

Description
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit. Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage. Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026). Distribution: U.S. Nationwide distribution in the state of California. Affected quantity: 112 kits
Hazard
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.

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