Z-0331-2027

Halyard MINOR PACK. Model/Catalog Number: VASF105-08

Name: Z-0331-2027 Halyard MINOR PACK. Model/Catalog Number: VASF105-08
Creator: AVID Medical, Inc.
Published: 2026-09-08
License: https://open.fda.gov/license/

AVID Medical, Inc. / initiated 2026-09-08 / Open, Classified

FDA source

Recall record

Recall number: Z-0331-2027
Status: Open, Classified
Initiated: 2026-09-08
Posted: 2026-11-03
Recalling firm: AVID Medical, Inc.
Product: Halyard MINOR PACK. Model/Catalog Number: VASF105-08.
Product code: LRO General Surgery Tray
Reason for recall: Potential for open seals on header bags, compromising sterility.
FDA root cause: Process control
Action: AVID Medical notified consignees on about 09/08/2026 via emailed "URGENT: MEDICAL DEVICE CORRECTION" letter. Consignees were instructed to Segregate, Quarantine, and Inspect all kits identified. If the header bag seal appears to be compromised, discard the entire kit. Consignees were also requested to complete and return the provided Recall Response Form. Distributors were instructed to notify customers if affected kits were further distributed. On 10/06/2026 AVID Medical sent an updated "URGENT: MEDICAL DEVICE CORRECTION" letter to consignees via email. The strategy was updated and consignees were instructed not to use the affected kits and that they should either discard or return them. If returning, they should contact customer service for a Return Goods Authorization. Consignees were again requested to complete and return the provided Recall Response Form. Distributors were again instructed to notify customers if affected kits were further distributed.
Quantity in commerce: 108 kits
Distribution: U.S Nationwide distributor in the state of Illinois.
Product codes and lots: Model/Catalog Number: VASF105-08. UDI-DI: 10809160451960. Lot Number: 1659384. Expiration Date: 9/30/2027.

Product code LRO

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 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-06. View this recall on fda.gov (opens on fda.gov)