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The FDA is aware that Medline has issued a letter to affected customers recommending certain Namic Manifolds be removed from where they are used or sold. Affected devices:
- Namic Angiographic Manifold
- Namic Preceptor Manifold
- Namic Compensator Manifold
- Medline Convenience Kits containing Namic 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 March 24, Medline has reported no serious injuries or deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medline at recalls@medline.com or 866-359-1704.
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