US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087
- 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:
- Fresenius Medical Care Holdings, Inc.
- Reason for Recall:
- Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Product Codes/Lot Numbers:
UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2141-2024
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