Z-1957-2016 Class II Terminated
FDA device recall Z-1957-2016 was initiated by Miami Fat Supply, Inc on April 21, 2016 and is designated Class II. 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. The recall status is terminated (terminated December 14, 2016). Affected quantity: 443 units.
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.