FDA Medical Device Recalls (openFDA)
Medical Action Industries, Inc. 306: Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
- Recall number
- Z-2792-2026
- Recalling firm
- Medical Action Industries, Inc. 306
- Product
- Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
- Status
- Open, Classified
- Initiated
- 2026-05-13
- Posted
- 2026-07-30
- Terminated
- not on file
- Reason
- 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.
- Root 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
- 657
- Distribution
- US: AZ, CO
- Lot, serial or model codes
- UDI-DI: 20809160490416. Lot/Expiration: 342513(1/16/2028), 336758(9/20/2027), 338977(1/16/2028)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEZ
- Firm FEI
- 1030451
- Firm city
- Arden
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28