BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2519-2025
    Event ID
    97316
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Lumicell, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 10, 2025
    Initiation Date
    July 31, 2025
    Classification Date
    September 4, 2025
    Address
    275 Washington St Ste 200, N/A, Newton, MA, 02458-1630, United States

    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.

    Code Info

    Model/Catalog Number: 900-00218 UDI-DIs: Sterile Cover 10-Pack Shipper Box Assembly: (01)0 0860008 53781 2, 840-00204 Assy, Dispenser Carton Sterile Cover: (01)0 0860003 25251 2, 810-00210 Assy, Outer Tray Sterile Cover: (01) 0 0860003 2520 5, Lot numbers: 43930, 43931, 43932, 43933, 42756, 44349, 44349-01, 44349-02, 44349-03, 44349-04;

    Distribution

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

    Quantity

    200 units (20 packs containing 10 units per pack)