Z-0205-2018 Class II Terminated
FDA device recall Z-0205-2018 was initiated by Won Industry Co. on January 13, 2017 and is designated Class II. Reason for recall: Distribution of unapproved devices with incorrect air compression level setup The recall status is terminated (terminated May 24, 2023). Affected quantity: 3.
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
- 3
Product Description
Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) 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
none