Recall Z-1957-2016 ยท MUU System, Suction, Lipoplasty
Miami Fat Supply, Inc
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.
| Date | Apr 21, 2016 |
| Status | Terminated |
| Reason | During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use. |
| Root cause | No Marketing Application |
| Action | Customers were sent an Urgent: Medical Device Recall/Correction letter, dated 04/19/2016, on 04/21/2016 that served as a notification of the Red Head 2 voluntary recall. Customers were informed that there were previous complaints of compromised product integrity and performance following sterilization. Lids are subject to fracture and fail after steam sterilization. Customers were advised to destroy used product and to ship unused product back to the manufacturer. Customers were to return an acknowledgement form to confirm their notification of the voluntary recall. |
| Quantity | 443 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.