FDA-Device2013-04-10Class II
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Advanced Sterilization Products
Hazard
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Sold states
US Nationwide Distribution
Affected count
1038 units
Manufactured in
33 Technology Dr, N/A, Irvine, CA, United States
Products
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1027-2013Don't want to check this manually?
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