Z-3108-2026Class I

Halyard IV START KIT NON-STERILE REF: KRIV26-02

Name: Z-3108-2026 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

FDA source

Recall record

Recall number: Z-3108-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-07-14
Posted: 2026-09-14
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 are contaminated with Aspergillus penicillioides
FDA root cause: Packaging process control
Action: On August 18, 2026, Avid Medical Inc. a subsidiary of Owens Minor issued an "Urgent Medical Device Recall Update" to affected consignees via email. The update was due to a revise recall strategy. Initial notification was sent on July 14, 2026. Avid ask consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product identified in TABLE 1. 2. Discontinue use of the BD ChloraPrep Clear - 1 mL and FREPP" Clear 1.5 mL Applicators. 3. FOR AVID KIT KRIV26-02, IV START KIT NON-STERILE, KIT LOT 1658437: Discard entire kit as it contains the contaminated component BD ChloraPrep" Clear - 1 mL, BD LOT 4032183. 4. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of the actions to take and maintain records of effectiveness. 6. Complete the attached Recall Response Form and return by August 28, 2026. If you have any questions, contact Manager, Regulatory Affairs at 470-280-4277.
Quantity in commerce: 288 units
Distribution: US Nationwide distribution in the state of NE.
Product codes and lots: Lot Number: 1658437 UDI: 10809160460481

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3108-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3108-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-14

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 2026-09-23. View this recall on fda.gov (opens on fda.gov)