Enforcement Report - Week of August 8, 2012
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Product Detail
| Product Description | Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment. |
|---|---|
| Recall Number | Z-2129-2012 |
| Classification | Class II |
| Code Info | Part Number 460730418 510(k) K052865 Lot number 2444750 |
| Product Distributed Qty | |
| Reason For Recall | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. |
Event Detail
| Event Id | 62538 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | ICU Medical, Inc. |
| City | San Clemente |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-17 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide distribution |
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