Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Code Number 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)
- 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:
- SPS Sterilization, Inc
- Reason for Recall:
- The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
Product Codes/Lot Numbers:
Code Number 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)
Distribution:
Distributed in: US, AZ, CA, FL, OH, PA, TX, VA, WV
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3038-2018
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