Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
- 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:
- Medtronic Perfusion Systems
- Reason for Recall:
- There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Product Codes/Lot Numbers:
UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
Distribution:
Distributed in: US, NY, OH, IL, NJ, MI, TN, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0289-2025
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