Sunstar Americas, Inc. - Feb. 17, 2015
Issue Date
Feb 17, 2015
Region
Central
Category
Device
$117.00
Contact Name
Richard D. McMahon
Contact Title
Managing Director, CFO
Address 1
1300 Abbott Dr.
City
Elgin
State
IL
Zip/Postal Code
60123-1821
Country
United States
Inspection Range
Feb 10, 2015 - Feb 17, 2015
Pages
3
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): Jesse A. Vazquez