The Red Head 2 Reusable Fat Harvesting Canister recalled over sterility concerns

Recall date

April 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Miami Fat Supply, Inc recalls The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneo…

Recall number

Z-1957-2016

FDA classification

Class II

Brand / firm

Miami Fat Supply, Inc

Sold / distributed

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.

Why it was recalled

During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.