FDAFDA · Food and drugs·Recall number Z-0406-2013
INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Published November 28, 2012 · Recall initiated: October 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carl Zeiss Meditec, Inc.
- Distributor
- Nationwide Distribution including IL and MD
- Lot
- Part number 304534-7500-002; lot number 540960.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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