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Early Alert: Convenience Kit Issue from Medical Action Industries
The FDA is aware that Medical Action Industries has issued an Urgent Medical Device Recall Notification to affected customers recommending certain angiographic syringes included in convenience kits be removed from where they are used or sold. The notification is for convenience kits that contain syringes affected by Medline’s Namic Angiographic Control Syringes with Rotating Adaptor (“Namic RA Syringes”) recall.
Medline Industries stated that the syringe rotating adaptor on affected devices may unwind during use, resulting in a loose connection or full disconnection between the syringe and manifold. If unwinding occurs, there is potential for biohazard exposure, blood loss, and infection. Loose connections or disconnections may 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.
Questions?
Customers in the U.S. with questions about this recall should contact Medical Action Industries at complaints@owens-minor.com.
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