FDA-Device2024-05-22Class II
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 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L
Medtronic Perfusion Systems
Hazard
Potential for unsealed sterile packing.
Sold states
Worldwide distribution.
Affected count
2622 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
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 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1800-2024Don't want to check this manually?
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