FDA Recall
Open, Classified
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Recall: Z-0506-2024
·
Initiated November 3, 2023
Recall
- Recall Number
- Z-0506-2024
- Event Number
- 93277
- Firm
- Liberty Medical Solutions, LLC
- FEI Number
- 3012251759
- Product Code
- IPF
- Status
- Open, Classified
- Root Cause
- Error in labeling
- Initiated
- November 3, 2023
- Posted
- December 7, 2023
- Address
- 3653 Madaca Ln, Tampa, FL, 33618-2048
Description
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Reason
The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
Action
Liberty Medical Solutions, LLC issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/03/2023 via US Mail. The notice explained the problem and provided an updated instruction manual.
Distribution
US Nationwide distribution in the states of CT, FL, NC, NJ, NY.
Quantity
473 units