BEUDAMED
    FDA Enforcement Class II Terminated

    COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

    Recall: Z-0774-2019 · Reported February 6, 2019

    Enforcement

    Recall Number
    Z-0774-2019
    Event ID
    81875
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wilson-Cook Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2019
    Initiation Date
    December 18, 2018
    Classification Date
    January 25, 2019
    Termination Date
    December 14, 2020
    Address
    4900 Bethania Station Rd, N/A, Winston Salem, NC, 27105-1203, United States

    Description

    COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

    Reason

    The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).

    Code Info

    Lot Number W4035256

    Distribution

    France, Ireland, Japan

    Quantity

    8 units