BEUDAMED
    FDA Enforcement Class II Terminated

    AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A, (10) PN: CDC-46702-1A, (11) CDC-47702-1A; (12) Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features, PN: ASK-45703-AH

    Recall: Z-1335-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1335-2018
    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

    AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A, (10) PN: CDC-46702-1A, (11) CDC-47702-1A; (12) Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features, PN: ASK-45703-AH

    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) 13F17F0049; (2) 13F17B0224, 13F17E0142, 13F17E0830; (3) 13F16L0220; (4) 13F17E0463, 13F17F0169; (5) 13F17E0685; (6) 13F17D0275, 13F17D0325; (7) 13F17C0470, 13F17D0243; (8) 13F17E0358; (9) 13F17B0031, 13F17E0626; (10) 13F17B0035, 13F17E0627; (11) 13F17B0135, 13F17D0191; (12) 13F16M0173, 13F17C0414

    Distribution

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