Class 2 Device Recall STERRAD 50

• Date Initiated by Firm: March 09, 2009
• Date Posted: June 15, 2009
• Recall Status: Terminated on March 14, 2012
• Recall Number: Z-1419-2009
• Recall Event ID: 51413
• 510(K)Number: K981625 K023290
• Product Classification: Ethylene Oxide Gas Sterilizer - Product Code FLF
• Product: 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.
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: Advanced Sterilization Products; 33 Technology Drive; Irvine CA 92618
• For Additional Information Contact: 949-453-6410
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 oil fill plugs. STERRAD NX System and/or STERRAD 50 System may potentially have defective oil fill plugs. Less than 1% of the installed STERRAD NX Systems have been affected. ASP has received 18 complaints in 10 months related to this failure for the STERRAD NX System. No complaints related to this issue for the STERRAD 50 System have been received. As of December 22, 2008, ASP has been actively replacing the plugs in these systems with stainless steel plugs during service calls and will continue to replace the oil fill plugs until all affected units are corrected. The letter advises that there is a risk of symptoms, such as nausea, shortness of breath, dry throat, burning, watery and blurry eyes, and headache occurring if customers inhale oil mist. If you see mist, haze or smoke in the room or detect an oil odor, personnel should complete the following: - Cancel the cycle if the sterilizer is running and as always, do not use instruments from an incomplete cycle - Leave the room - Avoid working in the room until the mist has cleared - Discontinue use of the STERRAD System until the system is repaired. Any additional questions can be directed to the Clinical and Technical Support staff at 1-888-4613.
• Quantity in Commerce: 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, Turkey, Middle East, Peru, Canada, Czech Republic, Portugal, South Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FLF and Original Applicant = ADVANCED STERILIZATION PRODUCTS