July 22, 2019

FDA: Class I recall of Alaris Infusion Sets

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration (FDA) on July 18 identified the recall by Becton Dickinson of its Alaris Infusion Sets for the Alaris Pump Model 8100 as Class I, the most serious.

The recall was initiated because of the potential for tube collapse that may cause unintended or faster than expected delivery of fluids, medications, blood, or blood products.

The FDA has received several medical device reports of tubing collapse associated with serious injuries.

Distribution dates were July 1, 2016, to April 18, 2019.

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