Device product
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
Z-0746-2014
Product summary
- Event
- Event 67043
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2366 units
- Official record key
device-enforcement:Z-0746-2014
Official wording
Reason: 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.
Code information: not available
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.