Z-1957-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2016
- Initiation Date
- April 21, 2016
- Termination Date
- December 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 443 units
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.
Distribution Pattern
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.
Code Information
Lots 1165 and 1271.