Carl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets
Carl Zeiss Meditec is recalling 36 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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Carl Zeiss Meditec, Inc. is recalling 36 INTRABEAM Balloon Applicator Sets, 3.0 cm, manufactured by Carl Zeiss Meditec AG in Oberkochen, Germany. The affected product is identified by part number 304534-7500-000 and lot number 540958. The INTRABEAM System is intended for radiation therapy treatments.
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 agency has classified this recall as Class II.
The affected units were distributed nationwide, including Illinois and Maryland. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
- Manufacturer
- Carl Zeiss Meditec, Inc.
- Hazard
- 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 304534-7500-000
- lot number 540958.
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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