Z-3109-2026Class II

Halyard IV Start Kit Non-Sterile REF: KRIV26-02

Name: Z-3109-2026 Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Creator: AVID Medical, Inc.
Published: 2026-07-14
License: https://open.fda.gov/license/

AVID Medical, Inc. / initiated 2026-07-14 / Open, Classified / root cause: packaging

FDA source

AVID Medical, Inc. began a recall of Halyard IV Start Kit Non-Sterile REF: KRIV26-02 on 2026-07-14. The reason FDA records is "Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3109-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-14
Posted: 2026-09-04
Recalling firm: AVID Medical, Inc.
Product: Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Product code: LRO General Surgery Tray
Reason for recall: Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On July 14, 2026, Avid Medical Inc. a subsidiary of Owens Minor issued an Urgent Medical Device Recall to affected consignees via email. I Avid Medical Inc. requested consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product identified. 1a. Discontinue use of the BD ChloraPrep" Clear - 1 mL and FREPP" Clear 1.5 mL Applicators. 1b. Add warning labels to affected AVID kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. 2. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 3. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 4. Complete the attached Recall Response Form and return by July 31, 2026.
Quantity in commerce: 98 Kits
Distribution: US Nationwide distribution in the state of NE.
Product codes and lots: Lot Number:1658438 7/31/2026 UDI: 10809160460481

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3109-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3109-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-04

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)