FDA-Device2026-07-29Class IIPROCESSING DEFECT
Halyard STANDARD LINE INSERTION PACK recalled for silicone seal defects causing fluid leakage risk
What this means
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.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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 recalls
- FDA-Device2026-09-09AVID Medical neurological surgical kits recalled for endotoxin variability in sponges
- FDA-Device2026-09-09Halyard medical convenience kits recalled for neurological sponges with inconsistent endotoxin levels
- FDA-Device2026-09-09Halyard medical surgical kits recalled for neurological sponges with variable endotoxin levels
- FDA-Device2026-07-29Halyard EYE PACK convenience kit recalled for incorrect Betadine solution concentration
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