CMExpress Microbore Sets, REF: A120-161C
Reported: July 22, 2020 Initiated: June 16, 2020 #Z-2580-2020
Product Description
CMExpress Microbore Sets, REF: A120-161C
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
Details
- Recalling Firm
- CME America, LLC
- Units Affected
- 50122
- 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
- Location
- Golden, CO
Frequently Asked Questions
What product was recalled? ▼
CMExpress Microbore Sets, REF: A120-161C. Recalled by CME America, LLC. Units affected: 50122.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2020. Severity: Critical. Recall number: Z-2580-2020.
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