Atrium Medical 24 Fr Trocar Catheter Recall for Labeling Error
Atrium Medical is recalling 24 Fr Trocar Catheters because the packaging label incorrectly depicts 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, with no reported injuries or illnesses.
Plain-English summary
Atrium Medical Corporation is recalling 5,005 cases of 24 Fr Trocar Catheters, Sterile (Model Number 8424). The recall is due to a labeling error where the packaging icon shows more holes (eyelets) than the catheter actually contains.
The affected devices are intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. The recall covers all lot codes and includes products distributed worldwide to the United States, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
Healthcare providers and consumers should stop using the affected devices and contact Atrium Medical Corporation for further instructions or a return.
The recalled product
- Product
- Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 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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