Sharesource Connectivity Platform for Use with the Amia Automated PD System
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code 5C9400, UDI: 45413765565692, 55413765565699
- 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:
- BAXTER HEALTHCARE CORPORATION
- Reason for Recall:
- Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Product Codes/Lot Numbers:
Product Code 5C9400, UDI: 45413765565692, 55413765565699
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2173-2021
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