ICU Medical, Inc. - Nov. 30, 2012
Issue Date
Nov 30, 2012
Region
Southwest
Category
Device
$117.00
Address 1
4455 Atherton Dr.
City
Salt Lake City
State
UT
Zip/Postal Code
84123-2504
Country
US
Inspection Range
Nov 26, 2012 - Nov 30, 2012
Pages
5
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Daniel J. Lahar and Nathan R. Moon