Z-2762-2015Class II

XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing...

Name: Z-2762-2015 XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing...
Creator: Revmedx Inc
Published: 2015-08-12
License: https://open.fda.gov/license/

Revmedx Inc / initiated 2015-08-12 / Terminated / root cause: packaging

FDA source

Revmedx Inc began a recall of XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose... on 2015-08-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2762-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-12
Posted: 2015-09-11
Terminated: 2015-09-17
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.
Product code: NAB Gauze / Sponge,Nonresorbable For External Use
Reason for recall: 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 tag: packaging
FDA 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 [email protected].
Quantity in commerce: 5004 units
Distribution: US Distribution to the states of : Arizona, Idaho, North Carolina, Tennessee and Virginia.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2762-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2762-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-11

Product code NAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)