Medtronic Perfusion Systems: Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.

Hazard

Potential for unsealed sterile packing.

Details from the source

Reason for recall: Potential for unsealed sterile packing. Distribution: Worldwide distribution. Quantity: 2622 units Lot/code info: a) Model Number 24009, GTIN 00673978178646, Lot Numbers: 2023040211, 2023040854, 2023041224; a) Model Number 24009, GTIN 20613994495420, Lot Numbers: 2023031043, 2023031563, 2023040211, 2023040480, 2023040854, 2023040855, 2023041224, 202305C108, 202305C109, 202306C196; b) Model Number 11316, GTIN 20613994676140, Lot Numbers: 2023040437; c) Model Number 11014L, GTIN 20613994495499, Lot Numbers: 2023040807, 2023040808, 202305C076, 202306C138

UPC codes

00673978178646, 20613994495420, 20613994676140, 20613994495499

Source

Official record: FDA (Device enforcement) ↗

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