Halyard IV Start Kit Non-Sterile recallZ-3109-2026 · 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 lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-3109-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 14, 2026
- Posted by the FDA
- Sep 4, 2026
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 98 Kits
- 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:1658438 7/31/2026 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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