INTRABEAM Balloon Applicator Set recall
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Why was INTRABEAM Balloon Applicator Set recalled?
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part number 304534-7500-001; lot number 540959.
- Product
- INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
- Recalling firm
- Carl Zeiss Meditec, Inc.
- Quantity
- 36 total, all lots
- Distribution
- Nationwide Distribution including IL and MD
- Recall date
- November 28, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)