Lumicell, Inc. — 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-
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 31, 2025
US Nationwide distribution in the states of CA, FL, MA, NC, TX.
What's affected?
- Product
- 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
- Brand
- Lumicell, Inc.
- Lot code
- 43930
Additional details
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;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 200 units (20 packs containing 10 units per pack).
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