Z-3260-2026Class II

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit...

Name: Z-3260-2026 Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit...
Creator: AVID Medical, Inc.
Published: 2026-07-22
License: https://open.fda.gov/license/

AVID Medical, Inc. / initiated 2026-07-22 / Open, Classified

FDA source

Recall record

Recall number: Z-3260-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-22
Posted: 2026-09-23
Recalling firm: AVID Medical, Inc.
Product: Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02
Product code: LRO General Surgery Tray
Reason for recall: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
FDA root cause: Packaging process control
Action: Consignees were initially notified on about 07/22/2026 via "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter. They were informed that product may exhibit an open or incomplete seal on the packaging of the applicator. Consignees were instructed to quarantine impacted product, discontinue use of the BD ChloraPrep Clear - 1 mL Applicators within the kits, add a warning label to instruct users to discard the impacted component, and notify customers if the kits had been further distributed. Consignees were notified again on about 08/20/2026 with an updated "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter. Consignees were informed that certain lots of the BD ChloraPrep Applicators are contaminated with Aspergillus penicillioides. Instructions included to discard impacted kits containing affected applicators and notify customers if the kits had been further distributed. For those unaffected by the contamination, but are included in the action regarding sterility concerns, they were instructed to quarantine impacted product, discontinue use of the BD ChloraPrep Clear - 1 mL Applicators within the kits, add a warning label to instruct users to discard the impacted component, and notify customers if the kits had been further distributed.
Quantity in commerce: 816 kits (17 cases)
Distribution: US Nationwide distribution.
Product codes and lots: Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Numbers (Expiration Date): 1658438 (07/31/2026), 1685838 (12/19/2027), 1699753 (02/28/2027), 1706455 (12/19/2027).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3260-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3260-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-23
Z-3261-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-23

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 2026-09-25. View this recall on fda.gov (opens on fda.gov)