CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets

Monday, August 3, 2020

CME America, a wholly-owned subsidiary of BD, announced a voluntary recall for all CME America BodyGuard® Infusion System Administration Sets (infusion sets)—used with the company’s BodyGuard® infusion pumps—that were distributed beginning May 2016 (see complete impacted product list below).  This action was initiated on June 16, 2020.

As part of CME America’s commitment to quality, following the previously announced recall (April 27, 2020) 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, CMEA 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.

Affected Product Types

BodyGuard BodySet

BodyGuard Microset with Needleless Adaptor

BodyGuard Microsets

BodyGuard Microset w/ Non-Vented Spike Connector

BodyGuard set with Female Luer

BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer

BodyGuard Microsets with Filter

Standard BodySet with Needleless Connectors

BodyGuard Microset with Filter and Manual Priming Valve

CMExpress Microbore Sets

BodyGuard Microset with Male Luer Connectors

CMExpress Needleless Y Site Microbore Set

See Customer Notification for full list of Affected Product Codes

Customer inquiries related to either recall, as well as adverse reaction/events experienced with the product should be addressed to CME America Support Center at 877-263-0111.

FDA MedWatch Reporting

FDA has been notified of this recall. Adverse reactions/events experienced with the use of any of these products should also be reported to the FDA’s MedWatch Program by:

  • Web: MedWatch website at www.fda.gov/medwatch
  • Phone: 1-800-FDA-108
  • Fax: 1-800-FDA-0178
  • Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

 

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