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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD 200 Sterilizer

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  Class 2 Device Recall STERRAD 200 Sterilizer see related information
Date Initiated by Firm February 25, 2008
Date Posted August 08, 2008
Recall Status1 Terminated 3 on November 21, 2011
Recall Number Z-1630-2008
Recall Event ID 47355
510(K)Number K030429  
Product Classification Chemical Sterilizer - Product Code MLR
Product STERRAD 200 Sterilization System, Product Code 10201

Used to sterilize heat and moisture sensitive reusable medical devices.
Code Information all serial numbers
Recalling Firm/
Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact
Manufacturer Reason
for Recall
Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke."
FDA Determined
Cause 2
Device Design
Action The firm sent an Urgent Device Correction letter dated 4/23/08, notifying customers of a situation that may occur with all models of STERRAD Sterilization Systems (100S, 50, 200, NX and 100NX). As a precaution, personnel should leave the room if mist is observed and avoid returning until the mist has cleared. ASP asks that customers circulate this letter to any STERRAD system users within their facility and also to the Chief Administrative Officer, the Director of Biomedical Engineering, Director of Materials Management and the Chief of Nursing. The letter instructs customers on what to do if they experience a filter failure - a) cancel the cycle if the sterilizer is running [and as always, do not use instruments from an incomplete cycle], b) leave the room, c) discontinue use of the STERRAD Sterilizer until the system is repaired. d) Personnel should avoid working in the room until the mist has cleared. The letter advises that ASP service will replace the sterilizer's filter and increase the frequency of filter changes by adjusting the Planned Maintenance (PM) schedule within the software on their STERRAD 100S and STERRAD NX Sterilizer. Per the notice, for each STERRAD Sterilizer model, ASP will do the following: a) STERRAD 200 Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter and gasket assembly at no charge. b) STERRAD NX Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter assembly at no charge and adjust the PM schedule to 650 cycles or 6 months (whichever occurs first). c) STERRAD 100S Sterilizer - beginning April 28, 2008 through October 2008, ASP will adjust the PM schedule to 750 cycles or 6 months (whichever occurs first). d) STERRAD 50 and 100NX Sterilizers - No adjustments to the oil mist filters or PM schedules are required at this time. PMs will be performed as currently scheduled. Information for MedWatch reporting is included in the letter.
Quantity in Commerce 9,950
Distribution Worldwide Distribution -- including USA and countries of France, Germany, Italy, United Kingdom, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Peru, Canada, Czech Republic, Middle East, Portugal, S. 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