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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD 50 Sterilization System

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  Class 2 Device Recall STERRAD 50 Sterilization System see related information
Date Initiated by Firm December 16, 2013
Date Posted January 14, 2014
Recall Status1 Terminated 3 on March 27, 2014
Recall Number Z-0745-2014
Recall Event ID 67043
510(K)Number K023290  
Product Classification Sterilizer, ethylene-oxide gas - Product Code FLF
Product STERRAD 50 Sterilization System, Product Code: 10050
The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
Code Information not available
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact
949-453-6400
Manufacturer Reason
for Recall		 Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.
FDA Determined
Cause 2		 Under Investigation by firm
Action Advanced Sterilization Products (ASP) sent an Urgent Medical Device Field Safety Notification dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the customer response forms. Customers with questions were also instructed to contact ASP Professional Services directly at (888) 783-7723 and select option number 2. For questions regarding this recall call 949-453-6400.
Quantity in Commerce 233 units
Distribution 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 = FLF and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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