Recall Z-2125-2014— DeRoyal Industries Inc

Name: FDA recall Z-2125-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-04

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2014-06-04, terminated 2015-05-05. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala. Reason: The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2014-06-04
Terminated: 2015-05-05
Firm location: Powell, TN, United States

Product description

DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala

Reason for recall

The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

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