Class I Recall of Becton Dickinson (BD) Alaris Infusion Sets for the Alaris Pump Model 8100

Published: 07/19/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Becton Dickinson (BD) is recalling Alaris Infusion Sets, due to the potential for faster than expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not in a "running status." The firm has determined that the silicone segment of the affected administration set has non-uniform thickness. Non-uniform wall thickness can lead to non-uniform tubing collapse and can contribute to a failure to fully occlude the tubing. This device defect may cause serio

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