Halyard IV START KIT NON-STERILE recallZ-3260-2026 · AVID Medical, Inc. · initiated Jul 22, 2026

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from AVID Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Packaging process control

What the company is doing

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.

Recall details

Recall number: Z-3260-2026
Status: Open, Classified
Initiated by the company: Jul 22, 2026
Posted by the FDA: Sep 23, 2026
Recalling firm: AVID Medical, Inc.
Quantity: 816 kits (17 cases)
Product code: LRO
Distribution: US Nationwide distribution.

Product description

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02

Code information (models, lots, serial numbers)

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).

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Halyard KRIV26-02_0003
Avid Medical, Inc. · General surgery tray
4 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 99764).

Z-3261-2026 · Open, Classified
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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