Halyard CATH LAB kit. Model Number: SACL75AM.

FDA device recall Z-1973-2026 · posted 2026-05-01 · Open, Classified

Recall details

Recalling firm

AVID Medical, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OES

Quantity affected

228 kits

Distribution

US distribution to FL, IL, MO, MS, NC, NE, TX.

Date initiated

2026-03-13

Date posted

2026-05-01

Location

Toano, VA