BD subsidiary CME America announces a voluntary recall for all CME America BodyGuard Infusion System Administration Sets—used with the company’s BodyGuard infusion pumps—that were distributed beginning May 2016.
As part of CME America’s commitment to quality, following the previously announced recall of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy identified in the earlier recall notification. Therefore, the use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm.
Based on those test results, CME America is providing additional information and customer actions regarding its previous recall to include all infusion sets used with the BodyGuard infusion pump distributed beginning May 2016. CME America has defined four categories of impacted infusion sets based on delivery inaccuracy variability, two of which (Category A and B) can continue to be used in accordance with the instructions in the recall letter.
CME America also announced on April 27, 2020, the decision to suspend distribution of the BodyGuard infusion pumps and to remove all existing products from the U.S. market. CME America will work with customers to address the latest expanded infusion set recall and will continue to maintain continuity of care during the COVID-19 pandemic. Until such time that the BodyGuard pumps have been removed from the market, CME America will supply accessories and infusion sets in “Category A” and “Category B” to support the infusion pumps, and customers can continue to use the products in accordance with the Operator’s Manual and the additional mitigations outlined in the customer letter.