Carl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets Due to Manufacturing Defect
Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets because a manufacturing defect could cause a small tube to become dislodged.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 failure 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, 3.5 cm. The product is intended for radiation therapy treatments and was distributed nationwide, including in Illinois and Maryland.
The recall was initiated due to a manufacturing defect that could result in a small tube becoming dislodged between the luer fitting and the check valve. The affected units have part number 304534-7500-001 and lot number 540959.
Healthcare facilities and consumers should stop using the affected INTRABEAM Balloon Applicator Sets and contact the recalling firm for further instructions.
The recalled product
- Product
- INTRABEAM Balloon Applicator Set; 3.5 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 304534-7500-001
- lot number 540959.
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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