BEUDAMED
    FDA Enforcement Class II Terminated

    Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD

    Recall: Z-1334-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1334-2018
    Event ID
    79512
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 18, 2018
    Initiation Date
    December 22, 2017
    Classification Date
    April 10, 2018
    Termination Date
    May 27, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD

    Reason

    Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

    Code Info

    Lot Numbers: (1) 13F17D0188, 13F17E0570; (2) 13F17E0660

    Distribution

    Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.