BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - 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, and Frequent blood sampling or receiving blood transfusions/blood products.

    Recall: Z-0282-2019 · Reported November 7, 2018

    Enforcement

    Recall Number
    Z-0282-2019
    Event ID
    81117
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2018
    Initiation Date
    August 30, 2018
    Classification Date
    October 26, 2018
    Termination Date
    July 31, 2020
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - 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, and Frequent blood sampling or receiving blood transfusions/blood products.

    Reason

    The product was shipped after its expiry date due to a system error. The product lidstock identifies the correct expiration date however the accompanying purchase order shipping documentation identifies an incorrect expiration date. Per standard clinical practice the lidstock would most likely be checked prior to use and the product would not be used leading to a minor delay while a replacement is located. In the unlikely event that the product lidstock is not checked prior to use, there is potential for use of expired product, and product functionality/or sterility cannot be guaranteed.

    Code Info

    23F16C0071

    Distribution

    US nationwide in the states of CA, FL, NC, and RI.

    Quantity

    105