Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304
- 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:
- Maquet Cardiovascular Us Sales, Llc
- Reason for Recall:
- Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Product Codes/Lot Numbers:
Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0986-2019
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