BEUDAMED
    FDA Recall Terminated

    Arrow Three-Lumen CVC

    Recall: Z-1290-2022 · Initiated May 5, 2022

    Recall

    Recall Number
    Z-1290-2022
    Event Number
    90147
    Firm
    ARROW INTERNATIONAL Inc.
    FEI Number
    3013162291
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    May 5, 2022
    Posted
    June 27, 2022
    Terminated
    September 4, 2024
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    Arrow Three-Lumen CVC

    Reason

    Gravity flow rates on the affected product lidstock are incorrect.

    Action

    A recall notification was issued to the consignee on 05/05/2022 via FedEx 2-day mail. The letter instructs the consignee to check the inventory, place a copy of the letter with all affected product and return the response form if the consignee is a medical facility. If the consignee is a distributor, the letter instructs the consignee to provide the notice to their customers, check the inventory, return the completed response form. An updated notification was sent on about 08/09/2022, via FedEx. The updated notification provided an additional description of the label error. Product scope remains the same.

    Distribution

    US Nationwide distribution in the states of Florida.

    Quantity

    10,301 units