BodyGuard set with Female Luer — Class I medical device recall Z-2582-2020
Terminated recall by CME America, LLC, reported 2020-07-22, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to p
| Recall number | Z-2582-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CME America, LLC, Golden, CO, United States |
| Recall initiated | 2020-06-16 |
| Classified | 2020-07-15 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2022-05-09 |
| Distributed | 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 |
| Countries outside the US | CA, GB |
| Quantity | 7,200 |
| Model numbers | A120-003XSN |
Product
BodyGuard set with Female Luer, REF: A120-003XSN
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2582-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.