Z-0204-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2017
- Initiation Date
- January 13, 2017
- Termination Date
- May 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.
Reason for Recall
Distribution of unapproved devices with incorrect air compression level setup
Distribution Pattern
Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
Code Information
Serial numbers: EMM16100968 and EMM16100967 MFG DATE: 2016.10.10