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FDA Issues Class I Recall for Becton Dickinson Needle Sets

By David Thornton Columbus, OH · HEALTH DESK

Published Updated 1 min read

The FDA issued a Class I recall for Becton Dickinson intraosseous needle sets due to a defect. The agency linked the malfunction to 45 serious injuries and four deaths.

Why It Matters

The recall involves a medical device used for emergency vascular access, with the defect resulting in patient harm. The agency action occurs as leadership changes are anticipated at the regulatory body.

What's New

Becton Dickinson has previously issued multiple recalls for its intraosseous needle sets, including a Class I recall in 2022 due to similar issues with stylet removal and device malfunction. In the 2022 recall, Becton Dickinson reported that 40,734 units were in commerce across the U.S. and Canada. Research titled The US FDA have issued a Class I recall for I-Flow Corporation's ON-Q Pump with ONDEMAND Bolus Button was published in 2012 in Reactions Weekly.

Outshine Fruit Bars, a brand under Dreyer's Grand Ice Cream, has not previously been involved in a recall related to foreign material contamination, making this the first such incident for the product line. Dreyer's Grand Ice Cream has a history of product recalls, including a 2021 recall of certain Ben & Jerry's pints over potential contamination with small pieces of metal.

How Sources Differ

Sources differ on details regarding Becton Dickinson intraosseous needle sets. The FDA Class I recall notice states that the FDA issued a Class I recall for Becton Dickinson intraosseous vascular access system needle sets due to a defect linked to 45 serious injuries and four deaths.

fact_check Facts

Relevance: primary · Type: action
Confidence100%
The FDA issued a Class I recall for Becton Dickinson intraosseous vascular access system needle sets due to a defect linked to 45 serious injuries and four deaths.
Source: FDA Class I recall notice
Relevance: primary · Type: event
Confidence90%
Sources stated that President Trump is expected to appoint White House aide Heidi Overton, MD, PhD, as the next FDA commissioner.
Relevance: supporting · Type: action
Confidence100%
Dreyer's Grand Ice Cream announced a nationwide recall of select flavors of frozen Outshine Fruit Bars due to possible contamination with glass.

menu_book Background & Sources

Context and data added by our newsroom from primary and authoritative sources — not in the original wire report.

Becton Dickinson has previously issued multiple recalls for its intraosseous needle sets, including a Class I recall in 2022 due to similar issues with stylet removal and device malfunction.
Source: accessdata.fda.gov
Research titled "The US FDA have issued a Class I recall for I-Flow Corporation's ON-Q Pump with ONDEMAND Bolus Button," was published in 2012 in Reactions Weekly.
Source: doi.org
Outshine Fruit Bars, a brand under Dreyer's Grand Ice Cream, has not previously been involved in a recall related to foreign material contamination, making this the first such incident for the product line.
Source: Dreyer's Grand Ice Cream Press Release
In the 2022 recall, Becton Dickinson reported that 40,734 units were in commerce, indicating a significant distribution of the affected products across the U.S. and Canada.
Source: accessdata.fda.gov
Dreyer's Grand Ice Cream has a history of product recalls, including a 2021 recall of certain Ben & Jerry's pints over potential contamination with small pieces of metal.
Source: Food and Drug Administration (FDA)

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