Atrium Medical Recalls 12 Fr Trocar Catheters Due to Labeling Error
Atrium Medical is recalling 12 Fr Trocar catheters because the packaging labels show 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 the hazard is a minor labeling error regarding the visual depiction of the product's features, which fits the criteria for a moderate severity score.
Plain-English summary
Atrium Medical Corporation is recalling 2,697 cases of 12 Fr Trocar catheters, Model Number 8412. 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 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 units were distributed worldwide, including in the United States, Canada, Australia, and numerous countries in Europe, South America, and the Middle East. All lot codes are included in this recall. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this labeling discrepancy.
The recalled product
- Product
- Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 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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