FDA-Device2020-07-22Class I
CMExpress Microbore Set, REF: A120-160CRV
CME America, LLC
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
Sold states
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
Affected count
402026
Manufactured in
14998 W 6th Ave Ste 830, N/A, Golden, CO, United States
Products
CMExpress Microbore Set, REF: A120-160CRV
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2568-2020Don't want to check this manually?
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