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U.S. Department of Health and Human Services

Class 2 Device Recall Red Head 2

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  Class 2 Device Recall Red Head 2 see related information
Date Initiated by Firm April 21, 2016
Create Date June 14, 2016
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-1957-2016
Recall Event ID 74156
Product Classification System, suction, lipoplasty - Product Code MUU
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.
Code Information Lots 1165 and 1271.
Recalling Firm/
Manufacturer		 Miami Fat Supply, Inc
1510 Max Hooks Rd Ste F
Groveland FL 34736-8032
For Additional Information Contact Mark Jordan
352-229-3595
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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