Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model

FDA device recall Z-1981-2026 · posted 2026-05-06 · Open, Classified

Recall details

Recalling firm

American Contract Systems Inc

Reason for recall

Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.

Action taken

Firm notified distributors with an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" dated March 19, 2026, via email. Distributors were instructed to notify end-users. An updated letter with additional kits was sent to the customer on 3/20/26. Customers should quarantine all affected product. Customers may add warning labels to affected ACS kits to ensure all users are aware of prescribed actions that were identified in the Medline recall notice. The warning labels state, "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." Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. If you have any questions, contact the Regulatory Affairs Manager, by email: gm-omra_recalls@owens-minor.com or at 419-455-2090.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

LRO

Quantity affected

7,311 kits

Distribution

US distribution to MN. No OUS distribution.

Date initiated

2026-03-19

Date posted

2026-05-06

Location

Tiffin, OH