INTRABEAM Balloon Applicator Set Recalled for Manufacturing Defect
Carl Zeiss Meditec is recalling INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a manufacturing defect that could lead to a component becoming dislodged during use. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Carl Zeiss Meditec, Inc. is recalling 36 units of the INTRABEAM Balloon Applicator Set, 4.0 cm. The product is intended for radiation therapy treatments. The recall covers all lots, specifically part number 304534-7500-002 and lot number 540960.
The recall was initiated because a manufacturing defect was identified that could result in the small tube becoming dislodged between the luer fitting and the check valve. The affected products were distributed nationwide, including in Illinois and Maryland.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
- Manufacturer
- Carl Zeiss Meditec, Inc.
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part number 304534-7500-002
- lot number 540960.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Carl Zeiss Meditec, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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