FDA recall Z-2558-2020

CME America, LLC · Class I · device

Product

BodyGuard Microset, REF: A120-160XSFK

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2020-06-16
Report date: 2020-07-22
Termination date: 2022-05-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Golden, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2558-2020