BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products

    Recall: Z-0723-2019 · Reported January 23, 2019

    Enforcement

    Recall Number
    Z-0723-2019
    Event ID
    81665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 23, 2019
    Initiation Date
    November 14, 2018
    Classification Date
    January 11, 2019
    Termination Date
    June 4, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products

    Reason

    The lidstock states the incorrect priming volume and flow rates.

    Code Info

    Lots 14F18F0336 & 14F18E0121

    Distribution

    Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, and Peru.

    Quantity

    15 in the US