FDA-Device2012-11-28Class II
INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
Carl Zeiss Meditec, Inc.
Hazard
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Sold states
Nationwide Distribution including IL and MD
Affected count
36 tootal, all lots
Manufactured in
5160 Hacienda Dr, N/A, Dublin, CA, United States
Products
INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0404-2013Don't want to check this manually?
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