Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds

FDA device recall Z-2792-2026 · posted 2026-07-30 · Open, Classified

Recall details

Recalling firm

Medical Action Industries, Inc. 306

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.

Action taken

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

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

OEZ

Quantity affected

657

Distribution

US: AZ, CO

Date initiated

2026-05-13

Date posted

2026-07-30

Location

Arden, NC