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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 17, 2003
Date Posted January 29, 2004
Recall Status1 Terminated 3 on September 10, 2004
Recall Number Z-0375-04
Recall Event ID 28031
Product Classification Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
Product Cidex Plus Test Strips
Code Information Product code 2924-Lot 010185 Product code 2926-Lot010252
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact Nevine Erian
949-453-6422
Manufacturer Reason
for Recall		 May not accurately detect minimum effective concentration (MEC)
FDA Determined
Cause 2		 Other
Action Recall was made by various emails sent 12/12/2003 to 12/19/2003. Customers are requested to quarantine and return product.
Quantity in Commerce 710 cases, 2 bottles per case
Distribution Nationwide. Japan, Puerto Rico, Latin America, Caribbean.
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.
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