Atrium Thoracic Catheter Recall Due to Incorrect Labeling Icon
Atrium Medical Corporation is recalling 1,394 cases of 10 Fr Straight Thoracic Catheters because the label icon incorrectly depicts six eyelets instead of 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 due to a labeling error (incorrect icon depiction) which is a minor labeling issue that may cause temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria.
Plain-English summary
Atrium Medical Corporation is recalling 1,394 cases of Atrium PVC 10 Fr Straight Thoracic Catheters (Code Number: 8010). The recall is due to a labeling error where the icon on the packaging depicts a catheter with six eyelets, whereas the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two.
The affected units are all lot numbers with an expiration date prior to December 2019. The product was distributed nationwide. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities should stop using the affected catheters and contact Atrium Medical Corporation for instructions on how to return or dispose of the product.
The recalled product
- Product
- Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
- 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 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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