Class 2 Device Recall STERRAD 100S Sterilizer

• Date Initiated by Firm: October 17, 2008
• Date Posted: November 21, 2008
• Recall Status: Terminated on November 29, 2011
• Recall Number: Z-0340-2009
• Recall Event ID: 50073
• 510(K)Number: K991999 K023290
• Product Classification: Chemical sterilizer - Product Code MLR
• Product: STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. ; ; ; 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 Dr; Irvine CA 92618
• For Additional Information Contact: 949-453-6410
• Manufacturer Reason for Recall: 1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injection of insufficient hydrogen peroxide sterilant and 2) Inability of the sterilizer to detect an obstruction in the door travel path while the door is closing. This situation can result in a hand b
• FDA Determined Cause: Component design/selection
• Action: Customer notifications will be sent the week of November 24, 2008. The notification letter (URGENT: Product Correction) will advise of two situations that could cause the STERRAD 100S Sterilizer to malfunction. The first situation involves the failure of the STERRAD 100S System to detect when an injection takes place without hydrogen peroxide having been transferred to the vaporizer bowl. This can occur under combinations of the following conditions: - the pneumatic pressure is low on the machine, or - the injector valve has a small leak, AND - a cassette fails to advance, or - a used cassette is re-inserted into the sterilizer. This situation can result in a cycle completion with insufficient hydrogen peroxide. The second situation involves the failure of the STERRAD 100S System to detect an obstruction in the door travel path while the door is closing. Under some conditions, the door sensors may become mechanically unsecured/disconnected and will not detect an obstruction. This situation can result in an operator's hand becoming pinched and bruised while the door is closing. To correct both situations above, Advanced Sterilization Products(ASP) has revised the software and is making physical hardware additions to the STERRAD 100S System. Contact ASP Customer Care Center at 888-783-7723, option 2 for questions or assistance.
• Quantity in Commerce: In the U.S., there are 2,623 units installed. There are also 3,701 units internationally.
• Distribution: Worldwide Distribution including USA and countries of France, Germany, Italy, UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, 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 = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS