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Overview

CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion

Recall Information
FDA

The BodyGuard Infusion Pump System delivers fluids and medications into a patient’s body in controlled amounts. The pump provides fluids through an infusion tubing set into a patient’s vein or through other cleared routes of administration. The system can be used in hospitals and home care environments.

Reason for Recall: CME America is recalling the BodyGuard Infusion Pump Systems because the pumps may have a slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion). The reason for the infusion errors is not known.

The use of the affected infusion pumps may cause serious adverse health consequences including death. There have been 158 complaints regarding this device issue. There have been no injuries or deaths.

Who May be Affected:

  • Health care providers using the BodyGuard Infusion Pump System
  • Home care providers using the BodyGuard Infusion Pump System
  • Patients who may receive fluids or medications delivered by the BodyGuard Infusion Pump System

For more information and for “what to do”, please visit: https://www.fda.gov/medical-devices/medical-device-recalls/cme-america-recalls-bodyguard-infusion-pump-system-due-risk-over-and-under-infusion?utm_campaign=FDA%20MedWatch%3A%20BodyGuard%20Infusion%20Pump%20System%20by%20CME%20America&utm_medium=email&utm_source=Eloqua

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