FDA-Device2025-09-10Class II
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
Lumicell, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of CA, FL, MA, NC, TX.
Affected count
200 units (20 packs containing 10 units per pack)
Manufactured in
275 Washington St Ste 200, N/A, Newton, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2519-2025Don't want to check this manually?
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