FDA-Device2016-06-22Class II
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
Miami Fat Supply, Inc
Hazard
During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.
Sold states
Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NM, NY, OH, TX, UT, and VA; and, the country of Dominican Republic.
Affected count
443 units
Manufactured in
1510 Max Hooks Rd Ste F, Groveland, FL, United States
Products
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1957-2016Don't want to check this manually?
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