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Recall Observatory FDA recall evidence

Device product

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

Z-1457-2025

February 21, 2025

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96443
Status
Ongoing
Classification
Class I
Quantity
468 units
Official record key
device-enforcement:Z-1457-2025

Official wording

Reason: 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.

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.

Distribution pattern: US: CA, FL, MN, NY, OH, OR, PA, TX, WV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.