What’s the Problem?
According to the FDA Recall Notice, this action affects all CME America BodyGuard Infusion System Administration Sets (infusion sets) used with the company’s BodyGuard infusion pumps distributed from May 2016 to July 2020.
The recall was issued after flow-rate accuracy testing by CME America found that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy. This means that use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm, FDA said.
Based on these problems, CME America has also decided to suspend distribution of the BodyGuard infusion pumps and to remove all existing products from the U.S. market. Click on the FDA Recall Notice to view a complete list of products affected.
This recall began on July 3, 2020.
Do I Have a BodyGuard Infusion Pump Recall Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in BodyGuard Infusion Pump Recall Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was injured by a recalled infusion pump, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.