Atrium Medical Recalls Trocar Catheters Due to Inaccurate Labeling
Atrium Medical is recalling 10 Fr Trocar catheters because the packaging label displays more holes than the product actually contains.
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 2/5 (Moderate).
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 and involves a minor labeling error where the packaging icon does not match the product's physical features. No injuries or illnesses are reported, and the hazard is limited to potential confusion regarding the device's specifications.
Plain-English summary
Atrium Medical Corporation is recalling 2,822 cases of 10 Fr Trocar catheters, Model Number 8410. These sterile medical devices are intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
The recall was initiated because the product packaging includes a label with an icon that shows 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 units were distributed worldwide, including in the United States, Australia, Canada, and numerous other countries. The recall covers all lot codes for this specific model. Healthcare providers and facilities that have received these products should stop using them and contact Atrium Medical for instructions on how to return the items.
The recalled product
- Product
- Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 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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