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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 62919
Product Type Devices
Status Ongoing
Recalling Firm Advanced Sterilization Products
City Irvine
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-01
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution, including Nationwide (USA).

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Product codes: 20390 (US), 20391 (EMEA and WW), 20394 (Canada), and 20690 (Korea). Class II 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. Z-2276-2012
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