FDA Device recall Z-0405-2013
INTRABEAM Balloon Applicator Set
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of INTRABEAM Balloon Applicator Set by Carl Zeiss Meditec, citing A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0405-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-25 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carl Zeiss Meditec |
| Distribution | US |
Product
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Reason
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Identifiers
| code_info | Part number 304534-7500-001; lot number 540959. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0405-2013%22
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