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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD 200

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 Class 2 Recall
STERRAD 200
see related information
Date Posted March 30, 2013
Recall Status1 Terminated on September 30, 2013
Recall Number Z-1027-2013
Recall Event ID 64692
Premarket Notification
510(K) Number
K030429 
Product Classification Sterilizer, Chemical - Product Code MLR
Product STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Code Information Codes: 10217 10201-002 10201 10202-001
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
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notification letter dated March 22, 2013 to all customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to report any complaints or suspected problems with their STERRAD 100NX and/or STERRAD 200 System to ASP Professional Services directly at (888) 783-7723 and select option #2.
Quantity in Commerce 1038 units
Distribution US Nationwide Distribution
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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