Reported Jun 22, 2016 · Terminated
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating…
Miami Fat Supply, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Miami Fat Supply, Inc · 1510 Max Hooks Rd Ste F · Groveland, FL · 34736-8032
Is this the product you have?
- 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.
- Lot codes and dates
- Lots 1165 and 1271.
- Amount recalled
- 443 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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