Becton Dickinson subsidiary CME America has announced a voluntary recall of all CME America BodyGuard Infusion System Administration Sets that are used with its BodyGuard infusion pumps.
In April, the company announced a recall of the BodyGuard Infusion Pump Systems and the suspension of its distribution and removal of all available products from the US market.
The latest recall follows an additional flow-rate accuracy testing conducted by the company. It was found in the test that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy identified in the earlier recall notification.
The company noted that the use of the pump system potentially could lead to over-infusion or under-infusion of therapy and patient harm.
The affected product types include BodyGuard BodySet, BodyGuard Microsets, BodyGuard Microsets with Filter and BodyGuard Microset with Male Luer Connectors.
Based on delivery inaccuracy variability, CME America has defined four categories of impacted infusion sets.
Two of these four categories can continue to be used in accordance with the instructions in the recall letter, the company noted.
CME America will supply accessories and infusion sets in these categories to support the infusion pumps.
The customers can continue to use the products in accordance with the operator’s manual and the additional mitigations outlined in the customer letter.
CME America also said it 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.