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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD 200

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  Class 2 Device Recall STERRAD 200 see related information
Date Initiated by Firm March 22, 2013
Date Posted March 30, 2013
Recall Status1 Terminated 3 on September 30, 2013
Recall Number Z-1027-2013
Recall Event ID 64692
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 CA 92618-2346
For Additional Information Contact
949-453-6400
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		 Nonconforming Material/Component
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 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
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