The Food and Drug Administration today announced a Class 1 recall of devices used to access blood vessels through a patient’s bone because the devices may malfunction, which could cause serious injury or death. Becton Dickinson recalled the over 36,000 intraosseous needle set and driver kits in June, and recommended customers quarantine the devices. FDA said 37 complaints have been associated with the recall, but no serious injuries or deaths.

Related News Articles

Headline
The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devices needing…
Headline
U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co.…
Headline
The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19…
Headline
In updated guidance for makers of medical devices labeled as sterile, the Food and Drug Administration Jan. 8 listed vaporized hydrogen peroxide as an…
Headline
The Food and Drug Administration the week of July 24 updated its recognized consensus standards database for medical devices to advance innovation in medical…
Headline
Commenting yesterday on the Environmental Protection Agency’s proposed standards for ethylene oxide use to sterilize medical devices, AHA encouraged the agency…