BD (NYSE:BDX) has issued a class I recall of its intraosseous needle set kits for its intraosseous infusion system.
BD issued the recall of its intraosseous needle set kits, manual driver kits and powered drivers due to three separate issues. The needle set kits stylets could be difficult to separate from the needle or not separate at all. The needle safety mechanism may not properly deploy as the stylet is removed from the intraosseous needle after placement. Metal discs in the powered driver are at risk of sticking and rendering the driver useless.
There have been 37 complaints and no serious injuries or deaths reported associated with the recall. BD initiated the recall on June 20, 2022, recommending customers quarantine all affected devices, destroy affected needle kits and do not use affected powered drives until a sales representative states it is safe to use. A sales representative will schedule a visit to inspect the powered drivers and repair them if needed.
Use of the recalled devices may cause delays in care due to the inability to place function intraosseous access, which is most often used in critically ill patients. There is also a risk of needle stick injuries for physicians using the system.
BD designed its intraosseous infusion system to gain access to blood vessels through a patient’s bone in emergency, urgent or medically necessary care. The access is used to inject or infuse medications/fluids for up to 24 hours in adults and children.
The recall affects BD intraosseous needle set kits, BD intraosseous manual driver kits and BD intraosseous powered drivers that were distributed between January 20, 2020, to May 5, 2022. There are 2,207 drills and 34,355 needle sets affected by the recall. Read product codes on the FDA website.
