CME America, LLC recalls BodyGuard Microset, REF: A120-161XPS

Recall date

June 16, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2557-2020

FDA classification

Class I

Brand / firm

CME America, LLC

Sold / distributed

U.S: CA, IN, LA, MO, FL, IL, ME, MN, CO, VA, OK, NE, GA, AL, KY, IA, MS, ID, TX, SC, OH, SD, NV, MI, WY, NC, PA, TN, KS, NJ, OR, AR, NM, MA, NY, DC, RI, MD, WA, WI, AZ, NH, UT, HI, AK, MT, ND, VT, CT. OUS (Foreign): Canada, UK

Why it was recalled

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BodyGuard Microset, REF: A120-161XPS