STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
This recall has been terminated (originally issued January 14, 2014).
- Company
- Advanced Sterilization Products
- Recall Initiated
- December 16, 2013
- Posted
- January 14, 2014
- Terminated
- March 27, 2014
- Recall Number
- Z-0744-2014
- Quantity
- 5584 units
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution
Lot / Code Info
not available
Root Cause
Under Investigation by firm
Action Taken
Advanced Sterilization Products (ASP) sent an Urgent Medical Device Field Safety Notification dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the customer response forms. Customers with questions were also instructed to contact ASP Professional Services directly at (888) 783-7723 and select option number 2. For questions regarding this recall call 949-453-6400.