BD’s recall of emergency vascular access devices labeled Class I event label by FDA

Becton Dickinson’s recall of devices used to access blood vessels through a patient’s bone has been labeled a Class by the Food and Drug Administration.

BD in June disclosed the recall of 11 needle set kits, manual driver kits and powered drivers that physicians use to access the vascular system via bone marrow in some emergency situations. Now, the FDA has categorized the recall as a Class I event because of the potential for the faults to delay the care of critically ill patients.