Enforcement Report - Week of November 28, 2012
-
Back to Previous Page
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 |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments | Part number 304534-7500-000; lot number 540958. | Class II | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. | 36 tootal, all lots | Z-0404-2013 |
| INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments. | Part number 304534-7500-001; lot number 540959. | Class II | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. | 36 total, all lots | Z-0405-2013 |
| INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments. | Part number 304534-7500-002; lot number 540960. | Class II | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. | 36 total, all lots | Z-0406-2013 |
-
