BEUDAMED
    FDA Enforcement Class II Terminated

    Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.

    Recall: Z-0465-2014 · Reported December 18, 2013

    Enforcement

    Recall Number
    Z-0465-2014
    Event ID
    66823
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2013
    Initiation Date
    November 6, 2013
    Classification Date
    December 6, 2013
    Termination Date
    January 13, 2014
    Address
    15 Wells St, Southbridge, MA, 01550-4503, United States

    Description

    Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.

    Reason

    KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.

    Code Info

    Lot Code YX

    Distribution

    Nationwide Distribution including states of: TX, PA, and NY.

    Quantity

    7 units