BEUDAMED
    FDA Recall Open, Classified

    Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM

    Recall: Z-2282-2023 · Initiated June 2, 2023

    Recall

    Recall Number
    Z-2282-2023
    Event Number
    92560
    Firm
    Covidien, LLC
    FEI Number
    3004904811
    Product Code
    EOX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 2, 2023
    Posted
    August 2, 2023
    Address
    3062 Bunker Hill Ln, Santa Clara, CA, 95054-1105

    Description

    Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM

    Reason

    Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.

    Action

    On 6/2/23, Medtronic sent recall notices to customers who were informed of the following: 1) If product was purchased directly from Medtronic, return affected product to Medtronic. 2) If product was purchased from a distributor, return affected product to the distributor. 3) The recall notice should be passed on to all who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 4) Complete and return the Customer Confirmation Form to [email protected] Adverse reactions or quality problems experienced with this product can be reported to Technical Support at [email protected] or call 1-800-448-3644 option 3.

    Distribution

    Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.

    Quantity

    6902