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RecallWatchMedical Device Safety
Class IOngoingZ-1981-2026

American Contract Systems Inc recalls Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating A…

American Contract Systems IncTiffin, OH, United StatesReported May 13, 2026 · 3 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80APANCA80AQ
    UDI-DI 191072232168
    19 affected lots
    42-8146111ANCA80AQ19107223667842-820721142-826771142-831131142-833761142-8353311
    +11 more42-837921142-840711142-851071142-857511142-861151142-871891142-871891242-872261142-880531142-882061142-8870911

What the firm is doing

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.

DistributionShow details

US distribution to MN. No OUS distribution.

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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