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The U.S. Food and Drug Administration (FDA) is aware that Aligned Medical Solutions has initiated an urgent Medical Device Recall notification for convenience kits containing syringes affected by Medline’s Namic Angiographic Control Syringes with Rotating Adaptor (“Namic RA Syringes”) recall.
The syringe rotating adaptor on affected devices may unwind during use, resulting in a loose or full disconnection between the syringe and manifold. If this occurs, there is potential for biohazard exposure, blood loss, and infection. Loose connections or disconnections may also introduce air into the line, which could result in air embolism. These conditions may lead to serious injury or death. All units have the potential to exhibit this failure mode.
As of March 13, Medline Industries has reported four serious injuries and no deaths associated with this issue.
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.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact contact Aligned Medical Solutions at fieldcorrectiveaction@alignedmedicalsolutions.com.
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