BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.

    Recall: Z-1965-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1965-2013
    Event ID
    65829
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    July 31, 2013
    Classification Date
    August 14, 2013
    Termination Date
    April 28, 2015
    Address
    2400 Bernville Road, Reading, PA, 19605, United States

    Description

    Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.

    Reason

    Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.

    Code Info

    Catalog # AK-17702-CDC, lot # RF2083258

    Distribution

    AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.

    Quantity

    156