Recall Z-0190-2014— Advanced Sterilization Products
Class II · Terminated
Class II FDA medical device recall by Advanced Sterilization Products, initiated 2013-10-18, terminated 2014-01-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.. Reason: Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps..
- Recalling firm
- Advanced Sterilization Products
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-18
- Terminated
- 2014-01-16
- Firm location
- Irvine, CA, United States
Product description
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
Reason for recall
Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps.
Data sourced from openFDA. This site is unofficial and independent of the FDA.