BEUDAMED
    FDA Recall Open, Classified

    Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

    Recall: Z-2146-2023 · Initiated May 18, 2023

    Recall

    Recall Number
    Z-2146-2023
    Event Number
    92575
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    HXK
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    May 18, 2023
    Posted
    July 14, 2023
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

    Reason

    Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.

    Action

    Aesculap Inc, a B. Braun company issued Urgent Medical Device Recall Notification Letter dated 5/18/23. Letter states reason for recall, health risk and action to take: Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and all concerned persons are informed about this voluntary product recall. 2. Determine your current inventory of the affected product within your facility. (See for instructions in identifying impacted devices.) 3. Cease use and quarantine product subject to recall. 4. Utilizing the attached "Product Recall Acknowledgement Form", record the total number of individual impacted pieces. If you have no inventory remaining, please enter zero (0) on the form. 5. Return the completed "Product Recall Acknowledgement Form" to Aesculap, Inc. Product Quality Excellence department by emailing the form to PA OualityAssurance.BBMUS [email protected] or faxing the form to (610) 849-1197 within two weeks of receipt, even if the total inventory in your possession is zero (0). 6. Once Aesculap, Inc. receives your acknowledgement form, a customer support representative will contact you with instructions on how to return any impacted pieces in your possession. Complete the acknowledgment form. Included with letter Instructions for Identifying Affected MD610 etched as MD611.

    Distribution

    US Nationwide distribution in the states of DC, MO, PA, TX.

    Quantity

    7 units