BEUDAMED
    FDA Enforcement Class II Terminated

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    Recall: Z-0104-2018 · Reported November 22, 2017

    Enforcement

    Recall Number
    Z-0104-2018
    Event ID
    78307
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo BCT, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 22, 2017
    Initiation Date
    October 20, 2017
    Classification Date
    November 16, 2017
    Termination Date
    August 21, 2020
    Address
    10811 W Collins Ave, N/A, Lakewood, CO, 80215-4440, United States

    Description

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    Reason

    The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. The expiration noted was not beyond initiation date of the recall. Since the product is noted as sterile, the clearance for K103340, K052925 and K991430 raises question if product was cleared with a sterility claim. Further post-market follow-up will be required to assess the safety risk of the product.

    Code Info

    UDI Case: 35020583514233, 51423 Each: 05020583514232, Lot 04A9939

    Distribution

    CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain

    Quantity

    281 units