Recall notification - Alaris Pump Infusion Sets

May 6, 2019

BD confirmed that infusion sets affected by this recall have a variation in the wall thickness of the pumping segment and therefore may not be fully occluded by the pump. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

Since this issue may lead to flow inaccuracies through the pumping cycle process, this may result in an over- infusion and the potential for serious patient injury or death, depending on the type of medication that is being delivered.

This recall has been associated with MDR reports, several of which are associated with serious injuries

BD has worked diligently with the supplier of the extruded tubing to put corrective actions in place to mitigate this occurrence.

If you require further assistance, please contact Regional Customer Quality at 888-237-2762, Opt 3, Opt2 Monday to Friday 8AM to 5PM (CT)for general questions or Customer Advocacy at 888-812-3266 7AM to 5PM (PST) for product complaints/Adverse Event Reports.


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