Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Class I - DangerousWhat Should You Do?
- Check if you have this product: Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567108605, 3000168086, 0684-00-0576-01; 10607567108605, 3000217952, 0684-00-0576-01; 10607567109633, 3000166607, 0684-00-0576-01U; 10607567109633, 3000169722, 0684-00-0576-01U; 10607567109633, 3000172352, 0684-00-0576-01U; 10607567109633, 3000172353, 0684-00-0576-01U; 10607567109633, 3000176574, 0684-00-0576-01U; 10607567109633, 3000176633, 0684-00-0576-01U; 10607567109633, 3000185680, 0684-00-0576-01U; 10607567109633, 3000196023, 0684-00-0576-01U; 10607567109633, 3000199196, 0684-00-0576-01U; 10607567109633, 3000199197, 0684-00-0576-01U; 10607567109633, 3000199198, 0684-00-0576-01U; 10607567109633, 3000200147, 0684-00-0576-01U; 10607567109633, 3000213850, 0684-00-0576-01U
- 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 Corporation
- Reason for Recall:
- Certain lots containing undersized dilator.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Product Codes/Lot Numbers:
Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567108605, 3000168086, 0684-00-0576-01; 10607567108605, 3000217952, 0684-00-0576-01; 10607567109633, 3000166607, 0684-00-0576-01U; 10607567109633, 3000169722, 0684-00-0576-01U; 10607567109633, 3000172352, 0684-00-0576-01U; 10607567109633, 3000172353, 0684-00-0576-01U; 10607567109633, 3000176574, 0684-00-0576-01U; 10607567109633, 3000176633, 0684-00-0576-01U; 10607567109633, 3000185680, 0684-00-0576-01U; 10607567109633, 3000196023, 0684-00-0576-01U; 10607567109633, 3000199196, 0684-00-0576-01U; 10607567109633, 3000199197, 0684-00-0576-01U; 10607567109633, 3000199198, 0684-00-0576-01U; 10607567109633, 3000200147, 0684-00-0576-01U; 10607567109633, 3000213850, 0684-00-0576-01U
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1686-2022
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