Reported Sep 10, 2025 · Ongoing
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper…
Lumicell, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lumicell, Inc. · 275 Washington St Ste 200 · Newton, MA · 02458-1630
Is this the product you have?
- Brand Name900-00218 Sterile Cover 10-Pack
- Shipper Box Assembly Product Name900-00218 Sterile Cover 10-Pack Shipper
- Box Assembly Model/Catalog Number900-00218 Sterile Cover 10-Pack
- Shipper Box Assembly Software VersionNot
- Applicable Product DescriptionSterile
- Cover ComponentLumicell Direct Visualization System (DVS) / PMA # P230014
- Lot codes and dates
- Model/Catalog Number900-00218
- UDI-DIsSterile
- Cover 10-Pack Shipper Box Assembly
(01)0 0860008 53781 2840-00204 Assy
- Dispenser Carton Sterile Cover
(01)0 0860003 25251 2810-00210 Assy
- Outer Tray Sterile Cover(01) 0 0860003 2520 5
- Lot numbers
43930439314393243933427564434944349-0144349-0244349-0344349-04
- Amount recalled
- 200 units (20 packs containing 10 units per pack)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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