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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD NX

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  Class 2 Device Recall STERRAD NX see related information
Date Initiated by Firm November 11, 2013
Date Posted November 26, 2013
Recall Status1 Terminated 3 on January 22, 2014
Recall Number Z-0403-2014
Recall Event ID 66815
510(K)Number K042116  
Product Classification Sterilizer, chemical - Product Code MLR
Product STERRAD NX, Product Code: 10033

The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code Information Please refer to consignee list
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 and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.
FDA Determined
Cause 2		 Labeling design
Action Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notificaiton letter on November 11, 2013, to all affected customers. The letter informed customers of the problems identified and the actions to be taken. Customers were instructed to provide the notice to anyone in their facility that needs to be informed and post this notice where appropriate. Customers were instructed to contact ASP at 1-888-783-7723 for any suspected problems. ASP is collaborating with KARL STORZ Endoskope to determine the sterilization impact of the suction port lumen material. Customers are instructed to contact KARL STORZ Endoskope Technical Support at (800)421-0837, ext 5350 for alternative reprocessing instructions. For questions regarding this recall call 949-453-6400.
Quantity in Commerce Total 4,381 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 = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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