Skip to content
Recall Observatory FDA recall evidence

Device product

BodyGuard Microset, REF: A100-163XSL

Z-2574-2020

June 16, 2020

Class I

Product summary

Firm
CME America, LLC
Event
Event 85650
Status
Terminated
Classification
Class I
Quantity
28600
Official record key
device-enforcement:Z-2574-2020

Official wording

Reason: 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

Code information: All lots within expiry

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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