PlainRecalls
FDA Devices Critical Class I Ongoing

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK

Reported: April 16, 2025 Initiated: February 21, 2025 #Z-1457-2025

Product Description

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK

Reason for Recall

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

Details

Units Affected
468 units
Distribution
US: CA, FL, MN, NY, OH, OR, PA, TX, WV
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 468 units.
Why was this product recalled?
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 16, 2025. Severity: Critical. Recall number: Z-1457-2025.