FDA-Device2026-07-29Class IIPROCESSING DEFECT
Halyard STANDARD LINE INSERTION PACK recalled for silicone seal defects causing fluid leakage risk
OTHERNationwide distribution
Halyard line insertion pack recalled for seal defect 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.
- If you have lot 1597314 (expires 8/31/2026) or lot 1599022 (expires 5/31/2026), do not use the kit.
- Contact AVID Medical, Inc. or your healthcare facility for guidance on replacement or safe disposal.
- Report any problems with the product to the FDA MedWatch program.
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.
Sold states
U.S. Nationwide distribution in the state of California.
Affected count
112 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2772-2026More AVID Medical, Inc. recalls
- FDA-Device2026-07-29Halyard EYE PACK convenience kit recalled for incorrect Betadine solution concentration
- FDA-Device2026-06-17Halyard Towel Six Pack recalled for non-sterilized sealed pouches
- FDA-Device2026-06-17Halyard Pain Pack Kit recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Eye Bag Pack recalled for non-sterilized sealed pouches
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