BEUDAMED
    FDA Recall Terminated

    Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.

    Recall: Z-2368-2020 · Initiated May 4, 2020

    Recall

    Recall Number
    Z-2368-2020
    Event Number
    85632
    Firm
    Resource Optimization & Innovation LLC
    FEI Number
    3004513970
    Product Code
    OFF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 4, 2020
    Terminated
    September 23, 2022
    Address
    645 Maryville Centre Dr, Ste 200, Saint Louis, MO, 63141-5846

    Description

    Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.

    Reason

    There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

    Action

    The firm's supplier mailed an Urgent: Field Action Notification dated 04/21/2020 The notification informs the customers to remove the affected product from inventory and place it in quarantine immediately. The notification included a label template for printing the appropriate warning label. The customers will affix the warning label on all affected kits affected by the notification in inventory. The label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Labels can be printed. The customers should send quantity and end user information request to the contact listed. The kits do NOT need to be returned and may be used. The letter states, an alternate saline flush solution should be used to accompany patient procedures until field action inventory is depleted. The notification states, if any of the affected products identified above were further distributed, to ensure all end-users are appropriately notified of the product recall. Recall Response Forms should be completed and returned as soon as possible even if customers have no current product inventory.

    Distribution

    US Nationwide distribution including in the states of MO, NC.

    Quantity

    9,360 units