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.
- 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
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.
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.
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.