FDAFDA · Food and drugs·Recall number Z-2772-2026
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Published July 29, 2026 · Recall initiated: May 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AVID Medical, Inc.
- Distributor
- U.S. Nationwide distribution in the state of California.
- Lot
- Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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