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Miami Fat Supply, Inc recalls The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcuta
Recalled June 22, 2016 · FDA recall Z-1957-2016 · Miami Fat Supply
Hazard
During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use. · FDA Class II
Units
443 units
Sold at
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.
Description
During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.
Product
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.
Manufacturer(s)
Miami Fat Supply, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →