Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
- 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:
- The electrical safety testing was not properly performed on the impacted devices and additional testing is required
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Product Codes/Lot Numbers:
Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
Distribution:
Distributed in: US, AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1316-2023
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