Recall Z-1158-2023— Cardinal Health 200, LLC

Name: FDA recall Z-1158-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-18

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2022-11-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A. Reason: 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.

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-11-18
Firm location: Waukegan, IL, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.