FDA Class I Recall: CME America BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump

March 19, 2020

The FDA has identified a Class I recall for the BodyGuard Infusion Pump System. This is the most serious type of recall because use of these devices may cause serious injuries or death.

The BodyGuard Infusion Pump System delivers fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is used in adult care in a hospital and home care environment.  The Microset Infusion Set (catalog umber A120-003XYVA) is one of the infusion sets that may be used with the BodyGuard Infusion Pump System.

CME America has identified that specific Microset Infusion Sets, Catalog Number A120-003XYVA, which have an extended section of tubing longer than standard lengths, prohibitively restrict medication flow to the pumping chamber of the infusion pump.  This restriction may result in under-infusion of the therapy. The patient may not receive the appropriate treatment, which could cause serious adverse health consequences including death.

CME America has received three complaints of under-infusion, but no injuries or deaths have been reported.  The issue was found during pump set-up testing, prior to use on patients.

On September 16, 2019, CME America, a subsidiary of Beckton Dickinson sent a letter to customers informing them of the issue and provided the following instructions:

Review inventory and discard all BodyGuard Microset Infusion Sets with catalog number A120-003XYVA.

FDA has the announcement.