Becton Dickinson’s recall of devices used to access blood vessels through a patient’s bone has been labeled a Class I event 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.
The recall affects 2,207 drills and 34,355 needle sets in the U.S. There have been 37 complaints with no serious injuries or deaths reported associated with the issues, the same number as when BD disclosed the recall earlier this year.
The FDA reiterated the information shared by BD in its recall notice. The company is recalling the device because of problems separating the stylet from the needle, the failure of the needle safety mechanism to deploy as the stylet is removed and the sticking of metal discs in the powered driver. The problems can cause loss of access to the blood, both because the entire needle assembly is removed or the stylet gets stuck, and render the powered driver unusable.
BD has asked customers to quarantine all affected devices. As the FDA restated in its recall notice, the company wants people to destroy affected needle kits and stop using powered drivers until a company sales representative determines they are safe to use.
There are no necessary follow-up activities for needles that have already been used or are currently in use and functioning properly, according to BD’s recall letter.