Recall Z-1957-2016— Miami Fat Supply, Inc
Class II · Terminated
Class II FDA medical device recall by Miami Fat Supply, Inc, initiated 2016-04-21, terminated 2016-12-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use..
- Recalling firm
- Miami Fat Supply, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-21
- Terminated
- 2016-12-14
- Firm location
- Groveland, FL, United States
Product description
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.
Reason for recall
During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.