August 11, 2022

FDA: Class I recall of BD Intraosseous Infusion System

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on August 11 classified the recall by Becton Dickinson (BD) of its Intraosseous Infusion System, which includes Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers, as Class I, the most serious.

The recall was initiated for three separate issues:

  • The stylet may be difficult to separate or may not separate from the needle, resulting in inadvertent removal of the entire needle assembly during placement.
  • The needle safety mechanism may not properly deploy as the stylet is removed after needle placement.
  • Metal discs may stick in the powered driver, making it unusable.

To date, there have been 37 complaints, no serious injuries, and no deaths associated with these issues. Distribution dates were January 20, 2020, to May 5, 2022.

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