FDA-Device2014-08-06Class II
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
DeRoyal Industries Inc
Hazard
The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
Sold states
Distributed in the states of MI, GA, OH, IL, MO, and IN.
Affected count
230 units
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2125-2014Don't want to check this manually?
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