Atrium Medical Recalls 8 Fr Thoracic Catheters Due to Labeling Error
Atrium Medical Corporation is recalling 8 Fr Straight Thoracic Catheters because the label depicts six eyelets instead of the correct two.
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, but the hazard is a minor labeling error with no reported injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Atrium Medical Corporation is recalling 660 cases of Atrium PVC 8 Fr Straight Thoracic Catheters (Code Number: 8008). The recall affects all lot numbers with expiration dates prior to December 2019. The product was distributed nationwide.
The recall was initiated due to a labeling error. The icon on the label depicts a catheter with six eyelets, whereas the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two. This discrepancy could potentially lead to confusion regarding the device's specifications.
Healthcare facilities and distributors should stop using the affected catheters and contact Atrium Medical Corporation for instructions on return or disposal. No injuries or illnesses have been reported in connection with this labeling error.
The recalled product
- Product
- Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Catheter
- 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 Numbers With Expiration Date Prior To December 2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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