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Revmedx Inc recalls XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded w
Recalled September 23, 2015 · FDA recall Z-2762-2015 · Revmedx
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. · FDA Class II
Units
5004 units
Sold at
US Distribution to the states of : Arizona, Idaho, North Carolina, Tennessee and Virginia.
Description
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.
Product
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 pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.
Manufacturer(s)
Revmedx Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →