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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Recall Number Z-0406-2013
Classification Class II
Code Info Part number 304534-7500-002; lot number 540960.
Product Distributed Qty 36 total, 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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