Recall Z-1981-2026 ยท LRO General Surgery Tray
American Contract Systems Inc
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
| Date | May 6, 2026 (initiated Mar 19, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 7,311 kits |
| Distribution | US distribution to MN. No OUS distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.