FDAAugust 12, 2015device
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile.
What to do
FDA enforcement status: Terminated
Brands named
revmedx
Recall history
No related federal recalls on record for this brand yet.
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