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FDA (Device enforcement)Recalled 2025-02-21class i

MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK

Hazard

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 from the source

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: US: CA, FL, MN, NY, OH, OR, PA, TX, WV Quantity: 468 units Lot/code info: 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.

UPC codes

10195327166304, 40195327166305, 10195327273484, 40195327273485, 10195327503390, 40195327503391

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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