AVID Medical, Inc. recalls Halyard IV Start Kit Non-Sterile REF: KRIV26-02

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-3109-2026
• FDA device classification · LROOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4370The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find AVID Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.