FDA Device recall Z-2580-2020
CMExpress Microbore Sets, REF: A120-161C
- FDA Device
- Class I
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class I recall of CMExpress Microbore Sets, REF: A120-161C by Cme America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2580-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-06-16 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cme America |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY |
Product
CMExpress Microbore Sets, REF: A120-161C
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
Identifiers
| code_info | All lots within expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2580-2020%22
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