Safety Alert: Class II: 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.
healthClass IIRecalled on Sep 10, 2025
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Nu
🔢 200 units (20 packs containing 10 units per pack)
Sold At: Lumicell, Inc.(US Nationwide distribution in the states of CA, FL, MA, NC, TX.)
Recall #: FDA-DEVICE-Z-2519-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 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;
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Summary
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.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Lumicell, Inc. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.