The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• CME America BodyGuard Microset Infusion Sets
• All Lots of affected Catalog Number
• Catalog Number:  A120-003XYVA
• Distribution Dates:  October 6, 2017 – July 15, 2019
• Devices Recalled in the U.S.:  91,500
• Date Initiated by Firm: September 6, 2019

Device Use

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.

Reason for Recall 

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.

Who May be Affected

• Health care providers using the BodyGuard Microset Infusion Set
• Home care providers using the BodyGuard Microset Infusion Set
• Patients who may receive fluids or medications delivered by the recalled Infusion Set

What to Do

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.
• Ensure that all users within the facility are aware of the recall.
• Complete the Customer Response Form attached to the letter and return it to the CME America, whether the product was in inventory or not.
• Report any adverse events to the FDA’s MedWatch Adverse Event Reporting program.

Contact Information

Customers with questions may contact the company at calling Customer/Technical Support at 303-936-4545 or 877-263-0111, Monday thru Friday from 9:00 am to 5:00 pm Mountain Time. 

Additional Resources:

1. Medical Device Recall Database Entry
2. CME America Recall Notice
3. CME America Customer Letter

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.