BEUDAMED
    FDA Recall Open, Classified

    Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

    Recall: Z-3222-2024 · Initiated July 23, 2024

    Recall

    Recall Number
    Z-3222-2024
    Event Number
    95220
    Firm
    Karl Storz Endoscopy
    FEI Number
    3007475226
    Product Code
    FGA
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    July 23, 2024
    Posted
    September 24, 2024
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017

    Description

    Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

    Reason

    Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

    Action

    On August 2, 2024, Karl Storz -Endoskope issued a "Urgent: Medical Device Correction" Notification to affected consignees via UPS Ground. Karl Storz asked consignees to take the following actions: 1. Immediately discard any previous revisions of the IFU. 2. Access the updated e-IFU at Karl Storz website 3. Pass on this Urgent Medical Device Correction to all users of the products listed and all other persons who need to be aware within your organization. 4. If you have further distributed the products listed, please identify and promptly notify those recipients of this notice and updated e-IFU. 5. Return the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 6. Please report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. 7. (Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.)

    Distribution

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

    Quantity

    78 units