Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001
- 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:
- Gambro Renal Products Inc
- Reason for Recall:
- Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
Product Codes/Lot Numbers:
Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0489-2015
Related Recalls
Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.