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U.S. Department of Health and Human Services

Class 2 Device Recall XGAUZE Trauma Dressing

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  Class 2 Device Recall XGAUZE Trauma Dressing see related information
Date Initiated by Firm August 12, 2015
Date Posted September 11, 2015
Recall Status1 Terminated 3 on September 17, 2015
Recall Number Z-2762-2015
Recall Event ID 72019
Product Classification Gauze/sponge,nonresorbable for external use - Product Code NAB
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.
Code Information 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; 
Recalling Firm/
Manufacturer		 Revmedx Inc
25999 Sw Canyon Creek Rd
Wilsonville OR 97070-9677
For Additional Information Contact
503-218-2172 Ext. 28
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 5004 units
Distribution US Distribution to the states of : Arizona, Idaho, North Carolina, Tennessee and Virginia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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