Device product
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
Z-0674-2017
Product summary
- Firm
- Terumo BCT, Inc.
- Event
- Event 75589
- Status
- Terminated
- Classification
- Class II
- Quantity
- 660
- Official record key
device-enforcement:Z-0674-2017
Official wording
Reason: 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.
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
Distribution pattern: Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
Derived failure modes
-
Labeling or packaging
incorrectly labeled