Date Initiated by Firm | June 23, 2009 |
Date Posted | October 20, 2009 |
Recall Status1 |
Terminated 3 on November 29, 2011 |
Recall Number | Z-0066-2010 |
Recall Event ID |
52632 |
510(K)Number | K031226 K994055 |
Product Classification |
Biological Sterilization Process Indicator - Product Code FRC
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Product | Sterrad CycleSure Biological Indicator, Product Code 14324.
The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles. |
Code Information |
All Lots. |
Recalling Firm/ Manufacturer |
Advanced Sterilization Products 33 Technology Drive Irvine CA 92618
|
For Additional Information Contact | 949-453-6410 |
Manufacturer Reason for Recall | Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time. |
FDA Determined Cause 2 | Device Design |
Action | An Important Product Labeling Correction - New Instructions for Use dated, June 26, 2009, has been proposed to be sent by the firm for Cyclosure Biological Indicators to consignees. The revised instructions reduce the maximum read time for the indicators to 3 days (72 hours). The letter also states why ASP changed the Instructions. Questions are to be directed to ASP Customer Care Center. |
Distribution | Worldwide 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 = FRC
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