FDA recall Z-2772-2026

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2026-05-19

Report date

2026-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2772-2026