FDA-Device2025-01-29Class II
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Medtronic Perfusion Systems
Hazard
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Sold states
Worldwide - US Nationwide distribution.
Affected count
745 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2025Don't want to check this manually?
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