Argon Medical Devices, Inc., 2018-10-22-2, Double Male LL Adapter

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of our pouched product.  Because of damage to a packaging die there is a possibility that the seal formed on the edge of the pouch may be incomplete for some product, which could result in a loss of sterility to the affected product.  Argon is recalling all product packaged with that die to prevent the inadvertent use of a potentially non-sterile device.  In addition to our communications to the field we will be communicating this issue to the US FDA and other Competent Authorities, as well as our Notified Body.

Fabrikant: Argon Medical Devices, Inc.
Product: Double Male LL Adapter