Z-1457-2025 Class I Ongoing
FDA device recall Z-1457-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on February 21, 2025 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 468 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2025
- Initiation Date
- February 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 468 units
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.
Distribution Pattern
US: CA, FL, MN, NY, OH, OR, PA, TX, WV
Code Information
TOL DR R PACK, UDI/DI 10195327166304 (ea) 40195327166305 (case), Lot Numbers 22GBL197, 22JBG283; TOL DR R PACK, UDI/DI 10195327273484 (ea) 40195327273485 (case), Lot Numbers 23ABO787, 23EBT153, 23HBB950; TOL DR R PACK, UDI/DI 10195327503390 (ea) 40195327503391 (case), Lot Numbers 24CBL126, 24EBV315, 24EBW136.