Cardiosave Rescue. Model Number: 0998-00-0800-83.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.
- 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:
- Datascope Corp.
- Reason for Recall:
- Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Product Codes/Lot Numbers:
Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1232-2023
Related Recalls
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There is discrepant labeling on the inner and outer packaging of the device.