FDA-Device2013-10-30Class II
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Advanced Sterilization Products
Hazard
Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Sold states
Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada
Affected count
1,305 units total (654 units in US , 651 OUS )
Manufactured in
33 Technology Dr, N/A, Irvine, CA, United States
Products
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0043-2014Don't want to check this manually?
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