CME America, LLC: Medical Device Recall in 2020 - (Recall #: Z-2580-2020)

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: A120-161C

Product Classification:

Class I

Date Initiated: June 16, 2020

Date Posted: July 22, 2020

Recall Number: Z-2580-2020

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: 50122

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