Reported Sep 23, 2015 · Terminated
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded…
Revmedx 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: Revmedx Inc · 25999 Sw Canyon Creek Rd · Wilsonville, OR · 97070-9677
Is this the product you have?
- 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.
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 Lot ESO54391, Expiration Date 9/25/2020 2 Lot ESO54725, Expiration Date 3/18/2020 3 Lot ESO54726, Expiration Date 3/30/2020 4 Lot ESO54741, Expiration Date 4/6/2020 5 Lot ESO54742, Expiration Date 4/13/2020 6 Lot ESO54743, Expiration Date 4/16/2020 7 Lot ESO54744, Expiration Date 4/23/2020 - Amount recalled
- 5004 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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