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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