BEUDAMED
    FDA Recall Terminated

    LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

    Recall: Z-2568-2014 · Initiated August 11, 2014

    Recall

    Recall Number
    Z-2568-2014
    Event Number
    69072
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    August 11, 2014
    Posted
    September 3, 2014
    Terminated
    February 5, 2015
    Address
    15 Law Dr, Fairfield, NJ, 07004-0011

    Description

    LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

    Reason

    During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.

    Action

    Maquet Inc.is sued an Urgent Medical Device Recall Letter/ Fax Back Form dated August 11, 2014. Customers are asked to quarantine the affected product and upon return they will be provided with an exchanged unaffected product. The attached form should be completed an returned to Maquet Inc. Questions can be directed to Maquet Technical Support at (888) 627-8383 - Press option "3" followed by option "1" Monday through Friday between the hours of 8 am and 5 pm (EST).

    Distribution

    US Distribution to TX.

    Quantity

    one unit