FDA Hits Cook Medical's Central Venous Cath Recall with a Class 1 Tag
The FDA today labeled Cook Medical‘s recall of its central venous catheter and pressure monitoring sets and trays as Class I over issues with tip splitting and separation.
The devices being recalled are used to monitor pressure in a patient’s vein or artery, to sample blood and to administer drugs or fluids.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The devices being recalled are used to monitor pressure in a patient’s vein or artery, to sample blood and to administer drugs or fluids.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.