AVID Medical, Inc.: Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.

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.

Details from the source

Reason for recall: 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. Distribution: U.S. Nationwide distribution in the state of California. Quantity: 112 kits Lot/code info: Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).

UPC codes

10809160416761

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.