CME America, LLC: Medical Device Recall in 2020 - (Recall #: Z-2579-2020)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2020.
Data Source: FDA.
Product Description:
CMExpress Microbore Sets, REF: A120-160C2YRV
Product Classification:
Class I
Date Initiated: June 16, 2020
Date Posted: July 22, 2020
Recall Number: Z-2579-2020
Event ID: 85650
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
Status: Terminated
Product Quantity: 4234
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
Voluntary or Mandated:
Voluntary: Firm initiated