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.
This recall has been terminated (originally issued March 30, 2013).
- Company
- Advanced Sterilization Products
- Recall Initiated
- March 22, 2013
- Posted
- March 30, 2013
- Terminated
- September 30, 2013
- Recall Number
- Z-1027-2013
- Quantity
- 1038 units
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide Distribution
Lot / Code Info
Codes: 10217 10201-002 10201 10202-001
Root Cause
Nonconforming Material/Component
Action Taken
Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notification letter dated March 22, 2013 to all customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to report any complaints or suspected problems with their STERRAD 100NX and/or STERRAD 200 System to ASP Professional Services directly at (888) 783-7723 and select option #2.