RecallRadar

FDA Device recall Z-2772-2026

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

On 2026-07-29 the FDA classified a Class II recall of Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01 by Avid Medical, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2772-2026
ClassificationClass II
Statusongoing
Initiated2026-05-19
Published2026-07-29
Last updated2026-09-13 11:58 UTC
CompanyAvid Medical
DistributionUS

Product

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

Reason

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.

Identifiers

code_infoModel/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2772-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.