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U.S. Department of Health and Human Services

Class 1 Device Recall Halyard Coronary Angio Pack

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 Class 1 Device Recall Halyard Coronary Angio Packsee related information
Date Initiated by FirmMarch 19, 2026
Date PostedMay 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1981-2026
Recall Event ID 98720
Product Classification General surgery tray - Product Code LRO
ProductConvenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Code Information ANCA80AP UDI-DI 191072232168 Lot 42-8146111 ANCA80AQ UDI-DI 191072236678 Lots 42-8207211 42-8267711 42-8311311 42-8337611 42-8353311 42-8379211 42-8407111 42-8510711 42-8575111 42-8611511 42-8718911 42-8718912 42-8722611 42-8805311 42-8820611 42-8870911
FEI Number 3008492337
Recalling Firm/
Manufacturer		 American Contract Systems Inc
85 Shaffer Park Dr
Tiffin OH 44883-9290
For Additional Information ContactMarlene Jones
419-455-2090
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionFirm 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.
Quantity in Commerce7,311 kits
DistributionUS distribution to MN. No OUS distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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