CME America, LLC
CME America, LLC appears in FDA public data with 48 recalls — including 39 Class I (most serious) —, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0527-2021, Class II) was initiated on July 30, 2020.
Summary
- Total Recalls
- 48 (39 Class I)
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0527-2021 | Class II | CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring c | July 30, 2020 |
| Z-0525-2021 | Class II | CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring contin | July 30, 2020 |
| Z-0528-2021 | Class II | CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring co | July 30, 2020 |
| Z-0526-2021 | Class II | CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring | July 30, 2020 |
| Z-0529-2021 | Class II | CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or f | July 30, 2020 |
| Z-0530-2021 | Class II | CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring contin | July 30, 2020 |
| Z-2577-2020 | Class I | BodyGuard Microset, REF: A120-160GCFA | June 16, 2020 |
| Z-2579-2020 | Class I | CMExpress Microbore Sets, REF: A120-160C2YRV | June 16, 2020 |
| Z-2556-2020 | Class I | BodyGuard Microset, REF: A100-163XES | June 16, 2020 |
| Z-2555-2020 | Class I | BodyGuard Microset, REF: A100-163XESV | June 16, 2020 |
| Z-2582-2020 | Class I | BodyGuard set with Female Luer, REF: A120-003XSN | June 16, 2020 |
| Z-2564-2020 | Class I | BodyGuard Microset with Filter, REF: A100-163XESF | June 16, 2020 |
| Z-2588-2020 | Class I | BodyGuard Microset With Female Luer, REF: A120-160XPSN | June 16, 2020 |
| Z-2586-2020 | Class I | CMExpress Microbore Set, REF: A120-160C | June 16, 2020 |
| Z-2571-2020 | Class I | BodyGuard Microset with Filter, REF: A120-160XSFE | June 16, 2020 |
| Z-2559-2020 | Class I | BodyGuard Microset, REF: A120-112XSFK | June 16, 2020 |
| Z-2576-2020 | Class I | BodyGuard Microset, REF: A120-125XSE | June 16, 2020 |
| Z-2581-2020 | Class I | BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF | June 16, 2020 |
| Z-2561-2020 | Class I | BodyGuard Microset, REF: A120-160XYSF | June 16, 2020 |
| Z-2562-2020 | Class I | BodyGuard Microset, REF: A120-161XYB | June 16, 2020 |