DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
FDA Recall #Z-0984-2025 — Class II — December 12, 2024
Product Description
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Reason for Recall
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Recalling Firm
Medtronic Perfusion Systems — Brooklyn Park, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
745 units
Distribution
Worldwide - US Nationwide distribution.
Code Information
Model 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated