Halyard IV START KIT NON-STERILE recallZ-3108-2026 · AVID Medical, Inc. · initiated Jul 14, 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 contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-3108-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 14, 2026
- Posted by the FDA
- Sep 14, 2026
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 288 units
- Product code
- LRO
- Distribution
- US Nationwide distribution in the state of NE.
Product description
Halyard IV START KIT NON-STERILE REF: KRIV26-02
Code information (models, lots, serial numbers)
Lot Number: 1658437 UDI: 10809160460481
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard KRIV26-02_0003Avid Medical, Inc. · General surgery tray4 recalls0 reports
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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