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U.S. Department of Health and Human Services

Class 2 Device Recall Adiprep Adipose Transfer System

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  Class 2 Device Recall Adiprep Adipose Transfer System see related information
Date Initiated by Firm November 03, 2016
Date Posted November 30, 2016
Recall Status1 Terminated 3 on March 02, 2017
Recall Number Z-0674-2017
Recall Event ID 75589
510(K)Number K121005  
Product Classification System, suction, lipoplasty - Product Code MUU
Product Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
Code Information Product Code: 51431, Lot Codes: 07Z9913; 07Z9933; 08Z9932; 09Z9908; 10Z9908 Product Code: 51432, Lot Codes: 08Z9907; 09Z9931. Product Code: 51433, Lot Codes: 08Z9901; 08Z9933. Product Code: 514001-347, Lot Codes: 05Z9956; 05Z9956; 07Z9917; 07Z9917; 07Z9917; 07Z9917; 05Z9956; 05Z9956; 07Z9917    
Recalling Firm/
Manufacturer		 Terumo BCT, Inc.
10811 W Collins Ave
Lakewood CO 80215-4440
For Additional Information Contact Debbie Trujillo,
303-231-4718
Manufacturer Reason
for Recall		 Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.
FDA Determined
Cause 2		 Error in labeling
Action Consignees will be notified on 11/07/16 via letter to contact the North America Terumo BCT support center at +1.877.842.7837 or +1.303.542.5050 if they have any affected product to issue a Return Goods Authorization for product return.
Quantity in Commerce 660
Distribution Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
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.
510(K) Database 510(K)s with Product Code = MUU and Original Applicant = HARVEST TECHNOLOGIES, CORP.
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