BEUDAMED
    FDA Enforcement Class II Terminated

    HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary

    Recall: Z-0075-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0075-2018
    Event ID
    78309
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo BCT, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2017
    Initiation Date
    October 20, 2017
    Classification Date
    November 8, 2017
    Termination Date
    March 26, 2021
    Address
    10811 W Collins Ave, N/A, Lakewood, CO, 80215-4440, United States

    Description

    HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary

    Reason

    Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.

    Code Info

    UDI Case 35020583514493, Each 05020583514492 Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019

    Distribution

    Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.

    Quantity

    525 kits