|
|
Angiographic Syringe Recall: Medline Industries Removes Namic Angiographic Rotating Adaptor Control Syringes
The FDA is aware that Medline Industries has issued an Urgent Medical Device Recall to affected customers recommending all Namic Angiographic Rotating Adaptor (RA) Control Syringes and Convenience Kits containing RA Syringes be removed from where they are used or sold.
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.
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 questions about this recall should contact Medline Industries at recalls@medline.com or 866-359-1704.
|
|
|
|
