Steris Corporation - October 28, 2009
Issue Date
Oct 28, 2009
Region
Southeast
Category
Device
$117.00
Address 1
2720 Gunter Park Dr. East
City
Montgomery
State
AL
Zip/Postal Code
36109
Country
US
Inspection Range
Oct 20, 2009 - Oct 28, 2009
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): Wendy R. Blame