Date Initiated by Firm | December 16, 2013 |
Date Posted | January 14, 2014 |
Recall Status1 |
Terminated 3 on March 27, 2014 |
Recall Number | Z-0744-2014 |
Recall Event ID |
67043 |
510(K)Number | K023290 K042116 |
Product Classification |
Sterilizer, chemical - Product Code MLR
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Product | STERRAD NX Sterilization System, Product Code: 10033
The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX 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
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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 | 5584 units |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MLR
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