Date Initiated by Firm | December 24, 2014 |
Date Posted | March 23, 2015 |
Recall Status1 |
Terminated 3 on September 04, 2015 |
Recall Number | Z-1312-2015 |
Recall Event ID |
70216 |
510(K)Number | K141693 |
Product Classification |
Wrap, sterilization - Product Code FRG
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Product | Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 |
Code Information |
Lot No. 68965-1241 |
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 Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | A customer notification letter was sent on 12/24/14 to all customers who purchased the expired Tyvek Rolls with STERRAD Chemical Indicator. The letter informs the customers of the problems identified and the actions to be taken. |
Quantity in Commerce | 2 units |
Distribution | Saudi Arabia and Portugal |
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 = FRG
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