Atrium Medical 16 Fr Trocar Catheter Labeling Error Recall
Atrium Medical is recalling 16 Fr Trocar Catheters because the packaging labels show more eyelets 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 physical product, with no reported injuries or illnesses.
Plain-English summary
Atrium Medical Corporation is recalling 2,172 cases of 16 Fr Trocar Catheters, Model Number 8416. The device is 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 trocar catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. This is a labeling discrepancy regarding the visual representation of the device's features.
The affected products were distributed worldwide, including in the USA, 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 facilities should verify the labeling on their inventory and contact Atrium Medical for further instructions.
The recalled product
- Product
- Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
- Manufacturer
- Atrium Medical Corporation
- 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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