INTRABEAM Balloon Applicator Set — Class II medical device recall Z-0404-2013
Terminated recall by Carl Zeiss Meditec, Inc., reported 2012-11-28, distributed nationwide. A manufacturing defect has been identified which could results in the small tube becoming dislodged between th
| Recall number | Z-0404-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec, Inc., Dublin, CA, United States |
| Recall initiated | 2012-10-25 |
| Classified | 2012-11-20 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2012-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 36 tootal |
| Lot numbers | 540958 |
| Model numbers | 304534-7500-000 |
Product
INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
Reason for recall
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0404-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.