Device product
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.
Z-1027-2013
Product summary
- Event
- Event 64692
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1038 units
- Official record key
device-enforcement:Z-1027-2013
Official wording
Reason: 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.
Code information: Codes: 10217 10201-002 10201 10202-001
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.