FDA Labels Cook Recall As A Class 1

The FDA has labeled the recall of Cook Medical’s single lumen central venous catheters and pressure monitoring sets and trays as Class 1, meaning it could cause serious injury or death. Read More

Synovis Handed 483 Over CAPA

FDA handed devicemaker Synovis a Form 483 for not initiating corrective and preventive actions for nonconformities to its Terminally Sterilized Vascu-Guard patch. Read More