American Contract Systems Inc recalls Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating A…
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 ANCA80APANCA80AQUDI-DI 19107223216819 affected lots42-8146111ANCA80AQ19107223667842-820721142-826771142-831131142-833761142-8353311
+11 more
42-837921142-840711142-851071142-857511142-861151142-871891142-871891242-872261142-880531142-882061142-8870911
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 detailsHide
US distribution to MN. No OUS distribution.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1981-2026
- 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 American Contract Systems IncSearch 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.
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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