BEUDAMED
    FDA Recall Open, Classified

    KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A

    Recall: Z-1981-2023 · Initiated April 5, 2023

    Recall

    Recall Number
    Z-1981-2023
    Event Number
    92182
    Firm
    Karl Storz Endoscopy
    FEI Number
    3007475226
    Product Code
    KCT
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    April 5, 2023
    Posted
    June 21, 2023
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017

    Description

    KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A

    Reason

    Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.

    Action

    On 4/5/23, correction notices were sent to customers informing them that new instructions for use were available: https://spwebspace.karlstorz.com/sites/RadelTrays/SitePages/Home.aspx 1) Ensure all relevant personnel in your organization review the notice and new Instructions for Use. 2) If you have previously sold or transferred any of the affected trays to a third party, please forward this notice to all such third parties. 3) Complete and return the acknowledgement form to [email protected] Customers with questions can email [email protected]. The following recalling firm phone number was provided: 800-421-0837

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, RI, SC, VA, VT, AL, CO, GU, IA, ID, KY, ME, MN, MT, ND, NE, NJ, NM, OK, PR, SD, TN, UT, WA, WI, WV, WY and the country of CA.

    Quantity

    4,386