| Class 2 Device Recall STERRAD 200 Carriage | |
Date Initiated by Firm | March 13, 2012 |
Date Posted | March 26, 2013 |
Recall Status1 |
Terminated 3 on May 28, 2014 |
Recall Number | Z-0998-2013 |
Recall Event ID |
64609 |
510(K)Number | K030429 |
Product Classification |
Sterilizer, chemical - Product Code MLR
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Product | STERRAD 200 System Carriage, P/N 10208.
Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer. |
Code Information |
N/A |
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 200 System Carriage because it can potentially become dislodged when an excessive load is applied. |
FDA Determined Cause 2 | Device Design |
Action | Advanced Sterilization Products (ASP) sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 13, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter informed the customers that ASP recently determined that the push bar located on the STERRAD 200 System Carriage can potentially become dislodged when an excessive load is applied. Customers with questions are instructed to contact Stericycle at (877) 931-0642. |
Quantity in Commerce | 2,457 units |
Distribution | Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom. |
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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