Z-0674-2017 Class II Terminated

Recalled by Terumo BCT, Inc. — Lakewood, CO

Recall Details

Product Type
Devices
Report Date
December 7, 2016
Initiation Date
November 3, 2016
Termination Date
March 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
660

Product Description

Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

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.

Distribution Pattern

Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.

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