Medtronic DLP Aortic Root Cannula with Flow-Guard recall: Sterility Concern
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Why was Medtronic DLP Aortic Root Cannula with Flow-Guard recalled?
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
- Product
- Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 420 units
- Distribution
- US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
- Recall date
- November 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)