Covidien LLC dba Uni-Patch
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0500-2013 | Class II | Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode i | February 9, 2012 |
| Z-0501-2013 | Class II | Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous el | February 9, 2012 |
| Z-0499-2013 | Class II | Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph | February 9, 2012 |
| Z-0498-2013 | Class II | Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutan | February 9, 2012 |