MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL

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: 1247 units Lot/code info: TOL DR R PACK, UDI/DI 10198459054242 (ea) 40198459054243 (case), Lot Number 24IBV027; TOL DR. C PACK, UDI/DI 10195327176914 (ea) 40195327176915 (case), Lot Number 22HBX339; TOL DR. CRESCENZO PACK, UDI/DI 10195327273750 (ea) 40195327273751 (case), Lot Numbers 22LBC389, 23EBQ439, 23HBG138; TOL DR. C PACK, UDI/DI 10195327513818 (ea) 40195327513819 (case), Lot Numbers 23KBS878, 24CBB191, 24EBD828; TOL DR. C PACK, UDI/DI 10198459054259 (ea) 40198459054250 (case), Lot Numbers 24FBO426, 24HBP282, 24JBL545, 24LBR173; TOL DR. M PACK, UDI/DI 10195327513825 (ea) 40195327513826 (case), Lot Numbers 23KBC932, 24CBP602, 24EBV519; TOL DR. M PACK, UDI/DI 10198459054266 (ea) 40198459054267 (case), Lot Numbers 24GBI558, 24GBX898, 24IBE173, 24IBE173A, 25ABG352.

UPC codes

10198459054242, 40198459054243, 10195327176914, 40195327176915, 10195327273750, 40195327273751, 10195327513818, 40195327513819, 10198459054259, 40198459054250, 10195327513825, 40195327513826, 10198459054266, 40198459054267

Source

Official record: FDA (Device enforcement) ↗

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