BEUDAMED
    FDA Recall Open, Classified

    Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.

    Recall: Z-1433-2023 · Initiated March 22, 2023

    Recall

    Recall Number
    Z-1433-2023
    Event Number
    91984
    Firm
    ROi CPS LLC
    FEI Number
    3014527682
    Product Code
    MLS
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 22, 2023
    Posted
    April 25, 2023
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758

    Description

    Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.

    Reason

    The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

    Action

    The recalling firm issued letters dated 3/22/2023 via email the same day. The letter explained the issue, identified the affected product, and listed the actions to be taken by the customer. The actions included checking their inventory for the affected product, segregate and quarantine all affected kits in their inventory, and use the attached label template to print warning labels to be affixed to all affected kits in their inventory. The label should be applied to each affected kit and outer product case in a prominent location to end users of the kits. The location chosen should not cover critical product information found on the existing label. The label instructs users to remove and discard the STERIS Light Handle Cover(s) when the kit is opened for use and to pull a sterile replacement from stock. A reply form is included with the letter for completion to indicate the consignee's actions in response to the notice. The response form is to be returned to the recalling firm via email. If the direct account consignee further distributed or forwarded the affected product, they are to immediately notify those customers. A copy of the ROi CPS recall letter, the letter from STERIS, and the attached label template may be included.

    Distribution

    US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

    Quantity

    70 kits