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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Revmedx Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Codes/Lot Numbers:
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;
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2762-2015