DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number 8G03458, Expiry Jul 2023
- 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:
- ConvaTec, Inc
- Reason for Recall:
- Primary packaging labeling may be incorrect.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Product Codes/Lot Numbers:
Lot Number 8G03458, Expiry Jul 2023
Distribution:
Distributed in: US, CA, FL, GA, IL, MD, MN, NC, NM, NJ, OH, PA, TX, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2614-2021
Related Recalls
Wound dressing may have foreign matter on the product.
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
The product does not meet sterility assurance level.