BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0465-2014 · Initiated November 6, 2013

    Recall

    Recall Number
    Z-0465-2014
    Event Number
    66823
    Firm
    Karl Storz Endoscopy America Inc
    FEI Number
    2020550
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 6, 2013
    Posted
    December 6, 2013
    Terminated
    January 13, 2014
    Address
    15 Wells St, Southbridge, MA, 01550-4503

    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.

    Action

    Karl Storz Endosocopy sent a Safety Alert letter dated November 6, 2013, to all customers who received the 33821DYD Axillent Debakey Grasping Forceps. The letter informed the customers of the problems identified and the actions to be taken. Customers were asked to set aside the mislabeled product and return the mislabeled instruments with the RMA (Return Material Authorization) number issued to them. Customers were instructed to fax or email completed recall response form to (424) 218-8519. Customers with any questions were instructed to call (800) 421-0837 ext 8289. For questions regarding this recall call 746-708-8440.

    Distribution

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

    Quantity

    7 units