The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
BodyGuard Infusion Pump Systems
All Serial Numbers of Affected Model Numbers
BG 323 Pump*
BodyGuard 121 Twins Pump*
BodyGuard 545 ColorVision Pump *
BodyGuard 575 Pump*
* Includes refurbished versions
Manufacturing Dates: March 06, 2009 to November 26, 2019
Distribution Dates: March 6, 2009 to November 29, 2019
Devices Recalled in the U.S.: 28,448
Date Initiated by Firm: January 7, 2020
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.