ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 20170928500311838 UDI: 07613327277852 07613327277937
- 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:
- Stryker Medical Division of Stryker Corporation
- Reason for Recall:
- Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Product Codes/Lot Numbers:
Serial Numbers: 20170928500311838 UDI: 07613327277852 07613327277937
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2212-2021
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