What’s the Problem?
This FDA Recall affects all BodyGuard Infusion System Administration Sets (infusion sets) used with CME America’s BodyGuard infusion pumps, which were distributed between May 2016 and July 2020.
The problem was identified after testing found that some CME infusion pumps failed to meet the ±5% delivery accuracy for the system or the ±13% accuracy. This means that use of the infusion pump could cause over-infusion or under-infusion of therapy and patient harm, according to the FDA.
As a result of these issues, CME America decided to suspend distribution of its BodyGuard infusion pumps and to remove all existing infusion sets from the market. See the Customer Notification for a complete list of products affected by the recall.
CME America is working with customers to address the infusion set recall and has pledged to maintain continuity of care during the COVID-19 pandemic.
This recall was announced by the FDA on July 8, 2020.
Do I Have a BodyGuard Infusion Pump Class Action Lawsuit?
The Class Action 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.