BEUDAMED
    FDA Recall 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 · Initiated July 31, 2013

    Recall

    Recall Number
    Z-1965-2013
    Event Number
    65829
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    July 31, 2013
    Posted
    August 14, 2013
    Terminated
    April 28, 2015
    Address
    2400 Bernville Road, Reading, PA, 19605

    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.

    Action

    An "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935.

    Distribution

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

    Quantity

    156