FDAFDA · Food and drugs·Recall number Z-2580-2020
CMExpress Microbore Sets, REF: A120-161C
Published July 22, 2020 · Recall initiated: June 16, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CME America, LLC
- Distributor
- 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
- Lot
- All lots within expiry
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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