Atrium Medical Recalls 8 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 8 Fr Trocar catheters because the packaging label displays an icon with more holes than the actual product contains.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling discrepancy without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Atrium Medical Corporation is recalling 1,617 cases of 8 Fr Trocar catheters, Model Number 8408. These sterile medical devices are intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. The recall covers all lot codes.
The recall was initiated because the product packaging includes a label with an icon that depicts more holes (eyelets) than the catheter actually contains. This discrepancy between the visual representation on the label and the physical product constitutes a labeling error.
The affected products were distributed worldwide, including in the United States, Canada, Australia, and numerous countries in Europe, South America, and the Middle East. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Catheters
- Hazard
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 (1)
- All lot codes
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 8 recalled by Atrium Medical Corporation 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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