Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments |
|---|---|
| Recall Number | Z-0404-2013 |
| Classification | Class II |
| Code Info | Part number 304534-7500-000; lot number 540958. |
| Product Distributed Qty | 36 tootal, all lots |
| Reason For Recall | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
Event Detail
| Event Id | 63596 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | Carl Zeiss Meditec, Inc. |
| City | Dublin |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-25 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including IL and MD |
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