AVID Medical, Inc.: Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- AVID Medical, Inc.
- Product
- Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S. Nationwide distribution in the state of California.
- Recall initiated
- 2026-05-19
- Code info
- Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).
- Product quantity
- 112 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Toano
- State
- VA
- Country
- United States
- Event id
- 99250
Free daily digest + "My products" watchlist