FDAJuly 31, 2025device
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 Di...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
lumicell
UPCs
00860008537812008600032525120086000325205
Recall history
No related federal recalls on record for this brand yet.
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