BEUDAMED
    FDA Recall Open, Classified

    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014

    Recall: Z-2519-2025 · Initiated July 31, 2025

    Recall

    Recall Number
    Z-2519-2025
    Event Number
    97316
    Firm
    Lumicell, Inc.
    FEI Number
    3017718237
    Product Code
    SAW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 31, 2025
    Posted
    September 4, 2025
    Address
    275 Washington St, Ste 200, Newton, MA, 02458-1630

    Description

    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014

    Reason

    The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially leading to surgical site infections.

    Action

    On July 31, 2025, URGENT: MEDICAL DECICE RECALL letters were sent to customers. Actions to be Taken by Customer: " Lumicell recommends that users dispose of the elastic bands and refrain from using them during the procedure. The Lumicell DVS may be used without elastic bands. " The elimination of elastic bands does not impact system performance. However, in the absence of elastic bands, there is a possibility that the secondary Sterile Probe Cover may shift during use. If this occurs, the Sterile Probe Cover may be repositioned, and Lumicell DVS use may continue. " If the included elastic bands are used, follow the Lumicell Direct Visualization System (DVS) Instructions for Use to ensure the bands are counted before and after the procedure to confirm the elastic bands are accounted for. " Please forward and post this notice for awareness to those who use it. If device was distributed or sold, please forward this notice to those accounts. " 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. Please acknowledge receipt of this letter by completing the included response card. Next Actions: Lumicell is investigating the root cause of the issue and is working on a long-term solution. Lumicell will contact you in the future regarding updates. If you have any questions or need further assistance, please do not hesitate to reach out to our customer support team at 1-833-4-LUM-DVS (Monday through Friday, 9AM - 5PM Eastern Time) or email [email protected].

    Distribution

    US Nationwide distribution in the states of CA, FL, MA, NC, TX.

    Quantity

    200 units (20 packs containing 10 units per pack)