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U.S. Department of Health and Human Services

Class 2 Device Recall CIDEX OPA

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 Class 2 Recall
CIDEX OPA
see related information
Date Posted August 27, 2012
Recall Status1 Terminated on September 11, 2013
Recall Number Z-2276-2012
Recall Event ID 62919
Premarket Notification
510(K) Number
K030004 
Product Classification Sterilant, Medical Devices - Product Code MED
Product CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
Code Information Product codes: 20390 (US).
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Manufacturer Reason
for Recall
The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action An "Urgent Medical Device Recall" letter dated August 10, 2012 was sent to all customers who purchased the CIDEX OPA solution, part #20390 (manufactured between May 2011 and April 2012). The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to notify their customers if they have distributed bottles of CIDEX OPA Solution to other locations. Customers were instructed to call Stericycle at (866) 629-6182 to arrange for return of the product.
Quantity in Commerce 1,310,844 units
Distribution Nationwide (USA) and Puerto Rico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MED and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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