Class 1 Device Recall

• Date Initiated by Firm: May 13, 2026
• Date Posted: July 30, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2792-2026
• Recall Event ID: 99337
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
• Code Information: UDI-DI: 20809160490416. Lot/Expiration: 342513(1/16/2028), 336758(9/20/2027), 338977(1/16/2028)
• FEI Number: 1030451
• Recalling Firm/ Manufacturer: Medical Action Industries, Inc. 306; 25 Heywood Rd; Arden NC 28704-9302
• Manufacturer Reason for Recall: Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels.
• FDA Determined Cause: Material/Component Contamination
• Action: On 5/13/2026, Owens & Minor emailed recall notices to customers who were asked to do the following: Identify, segregate, and quarantine all impacted product. Other components within the convenience kits can still be used once kit is properly labeled with the warning label below. Add warning labels to affected Medical Action kits to ensure all users are aware of the actions to remove and discard Manifold component as well as actions identified below and in the enclosed Medline recall notice. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Labels state in part: Prior to use, remove & discard the Medline Namic Angiographic (The Manifold). Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. Complete and return the response form via email to GM-OMRA_RECALLS@owens-minor.com Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com
• Quantity in Commerce: 657
• Distribution: US: AZ, CO
• Total Product Life Cycle: TPLC 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.