Z-2772-2026Class II

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

Name: Z-2772-2026 Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit
Creator: AVID Medical, Inc.
Published: 2026-05-19
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2026-05-19 / Open, Classified

FDA source

AVID Medical, Inc. began a recall of Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit on 2026-05-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2772-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-19
Posted: 2026-07-22
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Product code: OES Cardiac Catheterization 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.
FDA root cause: Process change control
Action: AVID Medical notified consignees on about 05/19/2026 via email. Consignees were instructed to identify, segregate, and quarantine all impacted kits, and add the provided warning labels to affected AVID kits to ensure all users are aware of discarding the impacted component prior to use. Distributors were instructed to ensure all end-users are properly notified if affected kits have been further distributed. Customers/End-users were instructed that if they have received product from a distributor, to contact the distributor or your sales representative with any questions. Recipients were requested to complete and return the provided Recall Response Form.
Quantity in commerce: 112 kits
Distribution: U.S. Nationwide distribution in the state of California.
Product codes and lots: Model/Catalog Number: PVHM234-01. UDI-DI: 10809160416761. Lot Numbers (Expiration date): 1597314 (8/31/2026), 1599022 (5/31/2026).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2772-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2772-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22

Product code OES

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)