RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: RTL190904 (Rental Units); UDI/DI: 00840861100965; Serial Numbers: 5K0S193320, 5K0S194164.
- 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:
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Product Codes/Lot Numbers:
Model Number: RTL190904 (Rental Units); UDI/DI: 00840861100965; Serial Numbers: 5K0S193320, 5K0S194164.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2346-2024
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