BEUDAMED
    FDA Recall Open, Classified

    Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

    Recall: Z-0363-2025 · Initiated October 21, 2024

    Recall

    Recall Number
    Z-0363-2025
    Event Number
    95607
    Firm
    Karl Storz Endoscopy
    FEI Number
    3007475226
    Product Code
    NVT
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    October 21, 2024
    Posted
    November 12, 2024
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017

    Description

    Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

    Reason

    Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

    Action

    On 10/22/2024, an "URGENT: MEDICAL DEVICE CORRECTION" Letters will be sent via email by KARL STORZ informing customers that the firm has become aware that one lot number of misbranded product was distributed to 19 customers. Customers are instructed to: 1. Pass on this Urgent Medical Device Correction to all users of the products listed above (Table 1) and all other persons who need to be aware within your organization. 2. Communicate to all applicable users that the product is not to be utilized during spinal procedures. 3. If you have or may have distributed the products listed, please identify and promptly notify those recipients of this notice. 4. Return the completed Customer Reply Form by E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 5. 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. for questions send an email to [email protected] .

    Distribution

    U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.

    Quantity

    40 units