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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 Recall
STERRAD 200 Sterilizer
see related information
Date Posted January 13, 2012
Recall Status1 Terminated on September 23, 2013
Recall Number Z-0741-2012
Recall Event ID 60889
Premarket Notification
510(K) Number
K030429 
Product Classification Sterilizer, Chemical - Product Code MLR
Product STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code Information Product Code 10201
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over time.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action ASP will send an Urgent Medical Device Correction letter to all affected customers on January 23rd, 2012. The letter describes the product, problem and the actions to be taken. The letter informs customers that ASP has determined that the vacuum pump in the STERRAD 200 System may cause the emission of a slightly increased level of hydrogen peroxide (H2O2) vapor into the surrounding environment if not regularly serviced or replaced. The letter instructed customers to read the "Issue Description" and "Recommendations" sections in the letter, pass on the notice with any staff that work with or around the STERRAD 200, and maintain awareness of this communication until ASP has serviced the system. Also, a list of FAQ was provided. The letter states that ASP will replace, free of charge, the vacuum pumps on all STERRAD 200 Systems that have exceeded the pump manufacturer's recommended service interval. ASP has contracted with Stericycle to manage this field correction. Telephone numbers are provided in the letter: for questions related to this field correction, please contact Stericycle at 1-877-225-9750 and to report any complaints or suspected problems with the System, please contact ASP Professional Services directly at 1-888-783-7723, option # 2.
Quantity in Commerce 395 units
Distribution Worldwide Distribution - USA (nationwide)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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