FDA-Device2014-01-22Class II

STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

Advanced Sterilization Products
Hazard

Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

Sold states
Nationwide Distribution
Affected count
233 units
Manufactured in
33 Technology Dr, Irvine, CA, United States
Products
STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0745-2014

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