Home / Recalls / Carl Zeiss Meditec, Inc. / Z-0406-2013

Z-0406-2013 Class II Terminated

Recalled by Carl Zeiss Meditec, Inc. — Dublin, CA

Recall Details

Product Type
Devices
Report Date
November 28, 2012
Initiation Date
October 25, 2012
Termination Date
November 20, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36 total, all lots

Product Description

INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.

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.

Distribution Pattern

Nationwide Distribution including IL and MD

Code Information

Part number 304534-7500-002; lot number 540960.

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