Recall Z-1419-2009 ยท FLF Sterilizer, Ethylene-Oxide Gas
Advanced Sterilization Products
STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
| Date | Jun 15, 2009 (initiated Mar 9, 2009) |
| Status | Terminated |
| Reason | ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs. |
| Root cause | Component design/selection |
| Action | Firm mailed out Urgent Device Correction letters dated March 9, 2009, advising customers/users that on April 23, 2008, Advanced Sterilization Products (ASP) initiated a device correction notification related to certain models of STERRAD Sterilization Systems that have the potential to emit oil mist due to a premature mechanical failure in the oil mist filter and/or filter assemblies. All affected STERRAD Systems have been corrected since the notification was issued. Recently, a secondary, lower-occurring cause of oil mist has been identified within the STERRAD NX System and STERRAD 50 System o |
| Quantity | 2,209 units installed in US; 2013 units OUS |
| Distribution | Worldwide Distribution -- USA, Germany, Italy, France, UK, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Thailand, Taiwan, Tur |
| FDA record | Open on fda.gov |