Early Alert: Convenience Kit Issue from Medical Action Industries

This communication is part of the Medical Device Recalls and Early Alerts Program.

If your email program has trouble displaying this email, view as a webpage.

Center for Devices and Radiological Health - Medical Device Early Alert

Early Alert: Convenience Kit Issue from Medical Action Industries

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

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. 

Read More

Questions?

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.

Manage Subscriptions | Unsubscribe All | Help


This email was sent to Esdek@podam.pl using Granicus Communications Cloud on behalf of: U.S. Food and Drug Administration · 10903 New Hampshire Ave · Silver Spring, MD · 20993-0002 · 1-888-INFO-FDA