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Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle Manifolds
The FDA is aware that AVID Medical has issued a letter to affected customers recommending certain convenience kits be corrected by removing manifolds affected by the Medline Namic Angiographic Star Off Handle Manifold Recall prior to continued use.
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 June 30, AVID Medical has not reported any serious injuries or deaths associated with this issue.
This recall involves correcting certain devices by removing components affected by another recall. 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 without correction.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact AVID Medical at complaints@owens-minor.com.
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