Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported July 22, 2020
CMExpress Microbore Set, REF: A120-161CYF
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cme America, LLC recalled CMExpress Microbore Set, REF: A120-161CYF - a critical-severity action.
CMExpress Microbore Set, REF: A120-161CYF was recalled by Cme America, LLC in July 22, 2020. Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to …. Check the official notice for the remedy. Verify recall #Z-2569-2020 with the FDA Devices before acting.
The recall
Cme America, LLC issued this critical-severity FDA Devices recall-Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to ….
- Critical
- severity level
- 25K units
- affected scope
- Class I
- classification
- July 22, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2569-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2569-2020) was formally reported on July 22, 2020, with the manufacturer initiating the action on June 16, 2020. It is classified under Critical severity (Class I), with a current status of Terminated. Cme America, LLC is listed as the recalling firm, operating out of Golden, CO. Federal records list the affected scope as 25286.
The documented reason for this recall is: 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 Distribution data in the federal record shows the product reached: 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): …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
25286
Related Recalls
6
0 from same agency
Product description
CMExpress Microbore Set, REF: A120-161CYF
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2569-2020 |
| Date reported | July 22, 2020 |
| Date initiated | June 16, 2020 |
| Recalling firm | Cme America, LLC |
| Firm location | Golden, CO |
| Affected scope | 25286 |
| 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2569-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CMExpress Microbore Set, REF: A120-161CYF. Recalled by Cme America, LLC. Units affected: 25286.
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-2569-2020.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2569-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 22, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.