BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0177-2015 · Reported November 12, 2014

    Enforcement

    Recall Number
    Z-0177-2015
    Event ID
    69512
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St Jude Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 12, 2014
    Initiation Date
    October 14, 2014
    Classification Date
    November 6, 2014
    Termination Date
    December 10, 2014
    Address
    1 Saint Jude Medical Dr, N/A, Saint Paul, MN, 55117-1789, United States

    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

    Code Info

    Batch # 4671318

    Distribution

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

    Quantity

    26