FDA Medical Device Recalls (openFDA)
Revmedx Inc: 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.
- Recall number
- Z-2762-2015
- Recalling firm
- Revmedx Inc
- 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.
- Status
- Terminated
- Initiated
- 2015-08-12
- Posted
- 2015-09-11
- Terminated
- 2015-09-17
- Reason
- 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.
- Root cause
- Package design/selection
- Action
- RevMedx, Inc. sent the Urgent Medical Device Correction and Removal XGAUZE Trauma Dressing letter to US Customers on August 12, 2015. Customers are instructed to inspect packages for signs of damages or loss of vacuum. The affected packages will appear puffy and the dressing will be loose inside. The non-affected packages will have a good vacuum intact seal and the packaging material should contour snugly against the dressing. Customers are advised to return any packages appear to have damaged or loss of vacuum. Any undamaged packages may be used as indicated. Customers with question can call the firm at (503) 218-2172 and fax the Return Response Form via fax to (503) 218-2274 or send via email to info@revmedx.com.
- Quantity
- 5004 units
- Distribution
- US Distribution to the states of : Arizona, Idaho, North Carolina, Tennessee and Virginia.
- Lot, serial or model codes
- Lot ESO54391, Expiration Date 9/25/2020; Lot ESO54725, Expiration Date 3/18/2020; Lot ESO54726, Expiration Date 3/30/2020; Lot ESO54741, Expiration Date 4/6/2020; Lot ESO54742, Expiration Date 4/13/2020; Lot ESO54743, Expiration Date 4/16/2020; Lot ESO54744, Expiration Date 4/23/2020;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAB
- Firm FEI
- 3009035955
- Firm city
- Wilsonville
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28