Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Recall
- Recall Number
- Z-1979-2026
- Event Number
- 98686
- Firm
- AVID Medical, Inc.
- FEI Number
- 1047429
- Product Code
- OES
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 13, 2026
- Posted
- May 1, 2026
- Address
- 9000 Westmont Dr, Toano, VA, 23168-9351
Description
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Owens and Minor/Avid Medical notified consignees on about 03/13/2026 and then sent an updated letter on about 03/18/2026 with additional kits added to the affected product list. The notice explained the issue was initiated by Medline Industries, risk associated with syringe disconnection and loose connection, and instructed consignees to identify, segregate and quarantine all affected product, and to apply warning labels to affected AVID kits to ensure all users are aware of the actions requested by Medline. 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. Per Medline, due to the risk of serious injury or death, customers are directed to remove and destroy all Namic RA Syringes. If use is unavoidable because failure to proceed would result in patient harm, the Namic RA syringe must be used with extreme caution and vigilance, including manual stabilization of syringe-to-manifold connections and continuous, 100% monitoring during setup and throughout the entire procedure. All usage guidelines and the Instructions for Use are provided in Medline s recall letter. Consignees were also instructed to complete and return the Recall Response Form as well as to notify customers if affected kits were further distributed to ensure all end-users are appropriately notified and maintain records of effectiveness.
US distribution to FL, IL, MO, MS, NC, NE, TX.
75 kits