Recall Z-0506-2024— Liberty Medical Solutions, LLC

Name: FDA recall Z-0506-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-03

Class II · Ongoing

Class II FDA medical device recall by Liberty Medical Solutions, LLC, initiated 2023-11-03. It names one FDA 510(k) clearance: K093138. Product: 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..

Recalling firm: Liberty Medical Solutions, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-11-03
Firm location: Tampa, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K093138 — MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003Shenzhen Dongdixin Technology Co., Ltd.·cleared 2010-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.