CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), has voluntarily recalled all CME America BodyGuard Infusion System administration sets, distributed from May 2016.

The infusion sets have been designed for use with the company’s BodyGuard infusion pumps, and the action of recall was started on 16 June, 2020.

The company has initially suspended the distribution of its BodyGuard infusion pumps and removed all the existing products from the US market starting from 27 April 2020.

Following the previously announced recall of the BodyGuard Infusion Pump systems, CME America has carried out additional flow-rate accuracy testing, as part of its commitment to quality.

The testing identified that some of the infusion sets did not meet the ±5% delivery accuracy for the system or the ±13% accuracy in the earlier recall notification.

Following the tests, it was concluded the company’s pump system may potentially cause over-infusion or under-infusion of therapy, along with patient harm.

Based on the test results, CME America has provided additional information and customer actions regarding its previous recall to include all infusion sets used with the BodyGuard infusion pump distributed from May 2016.

CME America identified four categories of impacted infusion sets

The company has defined four categories of impacted infusion sets based on delivery inaccuracy variability, of which Category A and B can continue to be used in accordance with the instructions in the recall letter.

CME America said that it will work with customers to address the recently expanded infusion set recall and will continue to maintain continuity of care during the Covid-19 pandemic.

Until the removal of BodyGuard pumps from the market, CMEA will supply accessories and infusion sets in Category A and Category B to support the infusion pumps.