BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0674-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0674-2017
    Event ID
    75589
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo BCT, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2016
    Initiation Date
    November 3, 2016
    Classification Date
    November 30, 2016
    Termination Date
    March 2, 2017
    Address
    10811 W Collins Ave, Lakewood, CO, 80215-4440, United States

    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.

    Code Info

    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

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

    Quantity

    660