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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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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; 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
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; 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
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