Recall Z-0674-2017
Terumo BCT, Inc. · initiated November 3, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
Codes / lots: 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
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: Error in labeling
Action taken
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.
Details
- Recall number
- Z-0674-2017
- Initiated
- November 3, 2016
- Posted by FDA
- November 30, 2016
- Terminated
- March 2, 2017
- Product code
- MUU – System, Suction, Lipoplasty
- Quantity
- 660
- Distribution
- Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
- Recalling firm
- Terumo BCT, Inc., Lakewood, CO