BEUDAMED
    FDA Enforcement Class II Terminated

    ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.

    Recall: Z-0602-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0602-2018
    Event ID
    78964
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    July 25, 2017
    Classification Date
    February 13, 2018
    Termination Date
    August 29, 2018
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.

    Reason

    Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.

    Code Info

    Lot/Batch Numbers: 13F16A0089, 13F16A0180, 13F17B0290, 23F16F0614.

    Distribution

    US nationwide distribution.

    Quantity

    2691 total