BEUDAMED
    FDA Enforcement Class II Terminated

    (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A

    Recall: Z-1324-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1324-2018
    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

    (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A

    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) 13F16L0254, 13F17B0196, 13F17C0046; (2) 13F17D0212, 13F17E0770, 13F17F0438; (3) 13F17E0656, 13F17F0188, 13F17F0459; (4) 13F17B0139, 13F17B0140, 13F17B0141, 13F17B0142, 13F17D0131, 13F17D0141, 13F17E0509, 13F17E0510, 13F17E0867, 13F17F0439; (5) 13F17C0339, 13F17E0230, 13F17E0718; (6) 13F16L0179, 13F17E0042, 13F17E0231, 13F17E0411, 13F17E0836

    Distribution

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