BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A

    Recall: Z-1170-2025 · Initiated January 15, 2025

    Recall

    Recall Number
    Z-1170-2025
    Event Number
    96075
    Firm
    Hologic, Inc
    FEI Number
    1000120743
    Product Code
    KNW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 15, 2025
    Posted
    February 13, 2025
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020

    Description

    Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A

    Reason

    Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

    Action

    On January 15, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Our goal is to create as little disruption to your practice as possible. Below outlines the next steps for customers with affected product(s): " Please quarantine any product(s) from the impacted lots you currently have in your inventory. Impacted lots can be returned through IQVIA as part of the voluntary recall. Please note that you will be issued a credit on your account for the affected product(s). " Refer to the Customer Response Form Instructions to identify your product inventory that is subject to this action. " Confirm receipt of this communication by completing the online Customer Response Form. Please complete and submit the online Customer Response Form even if you no longer have the affected product in inventory. Hologic has partnered with IQVIA to conduct follow up communications should no response be received to this letter. " Hologic will issue a Return Goods Authorization upon receipt of the Customer Response Form and the return of all affected products to Hologic. " If you wish to reorder product, please place a new order via your preferred procurement method. We value your business and thank you for your cooperation. If you have any questions about this communication, please contact [email protected] or 1-877-371-4372.

    Distribution

    Domestic: Nationwide Distribution

    Quantity

    55,335 units