FDA-Device2023-03-01Class II

Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A

Cardinal Health 200, LLC
Hazard

Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

Sold states
US Nationwide distribution in the states of GA, PA.
Affected count
36 EA
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1158-2023

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