Z-0289-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2024
- Initiation Date
- October 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 420 units
Product Description
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
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
Distribution Pattern
US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
Code Information
UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304