BEUDAMED
    FDA Recall Terminated

    St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353

    Recall: Z-0177-2015 · Initiated October 14, 2014

    Recall

    Recall Number
    Z-0177-2015
    Event Number
    69512
    FEI Number
    3007562768
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    October 14, 2014
    Posted
    November 6, 2014
    Terminated
    December 10, 2014
    Address
    St Jude Medical 1 Saint Jude Medical Dr, Saint Paul, MN, 55117-1789

    Description

    St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353

    Reason

    St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue

    Action

    St. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.

    Distribution

    US Distribution including the states of CA, GA, NJ, NY, OR and PA.

    Quantity

    26