FDA DeviceClass IINotable

FDA Recall: Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.

Date: 2026-07-29
Brand: AVID Medical, Inc.
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

112 kits

View original recall →
Share:

Related Recalls

2026-07-29 · FDA_DEVICE
FDA Recall: Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
AVID Medical, Inc.
2026-06-17 · FDA_DEVICE
FDA Recall: Halyard, Drape Pack. Kit Code: LMDP36-01.
AVID Medical, Inc.
2026-06-17 · FDA_DEVICE
FDA Recall: Halyard, Towel Six Pack. Kit Code: AMTS70-01.
AVID Medical, Inc.
2026-06-17 · FDA_DEVICE
FDA Recall: Halyard, Pain Pack. Kit Code: AMPK48-01.
AVID Medical, Inc.