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CME America, LLC recalls BodyGuard set with Female Luer, REF: A120-003XSN
Recalled July 22, 2020 · FDA recall Z-2582-2020 · CME America
Hazard
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 · FDA Class I
Units
7200
Sold at
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
Description
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
Product
BodyGuard set with Female Luer, REF: A120-003XSN
Manufacturer(s)
CME America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →