Recall Ledger

Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. ... recall (AVID Medical, Inc.)

Medical deviceClass IIOngoing

Summary: AVID Medical, Inc. is recalling 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.

What is being recalled

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

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

U.S. Nationwide distribution in the state of California. (states named: California)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2772-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMay 19, 2026
ReportedJuly 29, 2026
CompanyAVID Medical, Inc.
Company locationToano, VA, United States
Initiated byVoluntary: Firm initiated
Quantity112 kits

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