The US Food and Drug Administration (FDA) has issued a press release providing recommendations on how to handle the recent recall of Getinge/Maquet’s oxygenators used for extracorporeal circulation.
The move comes after Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to not use all Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs, on 18 May.
Getinge/Maquet recalled the devices due to the possibility of an accessory being improperly placed during packaging, causing creases and damage to the accessory’s sterile pouch as well as potential holes, cracks, dents, and crushed areas in the packaging. Exposure to a non-sterile or potentially non-sterile medical device could result in inflammation, infection, sepsis, and ischemia.
