Recall record at a glance
| Official record | Z-0205-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Won Industry Co. |
| Report date | Dec 13, 2017 |
| Recall initiation date | Jan 13, 2017 |
| Quantity | 3 |
| Location | Siheung-si, N/A, Korea (the Republic of) |
Official 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.
Why the product was recalled
Distribution of unapproved devices with incorrect air compression level setup
Distribution information
Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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