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Carl Zeiss Meditec, Inc. recalls INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended f

Recalled November 28, 2012 · FDA recall Z-0404-2013 · Carl Zeiss Meditec

Hazard
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. · FDA Class II
Units
36 tootal, all lots
Sold at
Nationwide Distribution including IL and MD

Description

A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.

Product
INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
Manufacturer(s)
Carl Zeiss Meditec, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov