The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The BD Intraosseous Infusion System is used by clinicians to obtain access to blood vessels through a patient’s bone (intraosseous) when emergency, urgent, or medically necessary care is needed but it is difficult or impossible for the clinicians to obtain typical access through the blood vessels (intravenously). This access can then be used to inject or infuse medications/fluids. It is used in both adults and children for up to 24 hours.
Becton Dickinson is recalling the BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits, and BD Intraosseous Powered Drivers for three separate issues:
These issues can cause delays in care due to the inability to place functional intraosseous access. Since intraosseous access is most often used in critically ill patients, including those with cardiopulmonary arrest or severe shock, the potential delays in care can cause serious injury or death. There is also the risk of needle stick injury.
There have been 37 complaints with no serious injuries or deaths reported associated with these recall issues.
On June 20, 2022, Becton Dickinson issued an Urgent Medical Device Recall letter recommending customers:
The letter also notes that there are no necessary follow-up activities when potentially affected intraosseous needles:
Customers with questions or concerns about this recall should contact Becton Dickinson North American Regional Complaint Center by phone at 1-844-8BD-LIFE (1-844-823-5433); say “Recall” when prompted or email productcomplaints@bd.com.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.