FDA-Device2025-01-29Class II

DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

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-0984-2025

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