Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper
Summary
The FDA issued a Class II for Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: by Lumicell, Inc.. 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.
Details
Source
Device Recall
External ID
Z-2519-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product 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
Lot/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;
Quantity Affected: 200 units (20 packs containing 10 units per pack)
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of CA, FL, MA, NC, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-31
Company
Newton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lumicell, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lumicell, Inc. have FDA actions?
This is the only FDA action we have on record for Lumicell, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2519-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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