FDA Issues Update on Becton Dickinson’s Recall

The FDA issued an update on Becton Dickinson’s June 20 recall of its Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits and Intraosseous Powered Drivers, deeming it a Class 1 recall because of the risk of serious injury and death.

The three products are part of the company’s Intraosseous Infusion System, which is used to access blood vessels through a patient’s bone for injections or infusions when it is difficult or impossible for clinicians to obtain access through blood vessels.

The recall was prompted by several potential issues. The stylet may be difficult to separate from the needle or may not separate at all, which can lead to loss of intraosseous access. Also, the needle’s safety mechanism may not properly deploy as the stylet is removed from the intraosseous needle after placement. There is also a risk of metal discs sticking in the powered driver, which may make it unusable.

The issues can lead to delays in care and cause serious injury or death, the agency said. The 2,207 drills and 34,355 needle sets were distributed from Jan. 20, 2020 to May 5.

There have been 37 complaints but no serious injuries or deaths reported in connection with the recall, the agency said.