BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0674-2017 · Initiated November 3, 2016

    Recall

    Recall Number
    Z-0674-2017
    Event Number
    75589
    Firm
    Terumo BCT, Inc.
    FEI Number
    1000117351
    Product Code
    MUU
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    November 3, 2016
    Posted
    November 30, 2016
    Terminated
    March 2, 2017
    Address
    10811 W Collins Ave, Lakewood, CO, 80215-4440

    Description

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

    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.

    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.

    Distribution

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

    Quantity

    660