Early Alert: Convenience Kit Issue from Medical Action Industries

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.  

Affected Product

The FDA is aware that Medical Action Industries has issued a letter to affected customers recommending certain Convenience Kit be removed from where they are used or sold. Affected devices:

• Kit: Pack Angiography NCMC 3/Cs BANNER
  • UDI 20809160490416
  • Lot 342513
  • Lot 336758
  • Lot 338977

What to Do

Remove and destroy affected Namic Manifolds. Apply over-labels to all affected kits on hand stating that the affected manifolds must be removed and discarded from further use.

On May 13, Medical Action Industries sent all affected customers a letter recommending the following actions:

• Immediately check your stock for any affected product and quarantine. Destroy affected product after completing recall response forms. Other components within the convenience kits may still be used.
• Apply provided over-labels to any affected kits on hand stating that the affected manifolds must be removed and discarded from further use.
• If you are a distributor or have resold or transferred this product, notify them of this recall communication.
• If use is unavoidable because failure to proceed would result in patient harm, the Manifolds must be used with extreme caution and vigilance. In such cases:
  • The user should perform a full flush of the Manifold and associated tubing with saline.
  • Carefully examine the manifold and lines for any particulate.
  • Do not use the Manifold and lines if any particulate is observed.
  • Users should otherwise adhere to all usage guidelines and the Manifolds’ Instructions for Use.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available. 

Reason for Alert

Medical Action Industries initiated an urgent Medical Device Recall notification for Convenience Kits that contain Medline’s Namic Angiographic Star Off Handle Manifolds.

Medline identified the presence of particulate within the fluid path of the Manifolds. Particulate within the Manifold fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels. This carries a risk of serious injury, such as tissue or organ ischemia, or death.

As of May 13, Medical Action Industries has reported no serious injuries or deaths associated with this issue.

Device Use

The Namic Manifold is intended to be used for fluid management, contrast media and pressure monitoring.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medical Action Industries at complaints@owens-minor.com.

Additional FDA Resources

• Manifold Recall: Medline Removes Namic Star Off Handle Manifolds [05/26/2026]

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.