Home / Recalls / Medical Devices
Carl Zeiss Meditec, Inc. recalls INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended f
Recalled November 28, 2012 · FDA recall Z-0406-2013 · 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 total, 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; 4.0 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 →