Atrium Firm PVC Thoracic Catheter Recall Due to Expiration Date Mismatch
Atrium Medical Corporation is recalling Atrium Firm PVC Thoracic Catheter 28French due to an expiration date mismatch between the sterile barrier pouch and case labels. The discrepancy allowed product to be used up to five days past its true expiration date.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall. No illnesses or injuries have been reported. The expiration date mismatch allowed use of expired sterile medical device in a high-risk thoracic cavity, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' warranting a High (3) severity score.
Plain-English summary
Atrium Medical Corporation is recalling Atrium Firm PVC Thoracic Catheter 28French (Product REF Number: 15028) due to an expiration date mismatch between the sterile barrier pouch label and the case/shipper labels. The sterile barrier pouch was labeled with an expiration date of September 16, 2024, while the case and shipper labels showed September 21, 2024. This discrepancy meant the product could be used for up to five days past its true expiration date, potentially compromising the sterile barrier.
The affected product was distributed to healthcare facilities in Arizona, Illinois, Kansas, Louisiana, Michigan, New York, Ohio, Oklahoma, Texas, and Virginia. A total of 56 cases (560 units) with lot number ME231010 were distributed.
Healthcare facilities and users of this product should verify the expiration dates on both the sterile barrier pouch and case/shipper labels. Any units with mismatched dates should be removed from service and not used. Users should contact Atrium Medical Corporation for further instructions on product replacement or correction.
The recalled product
- Product
- Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
- Manufacturer
- Atrium Medical Corporation
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)
- UDI-DI: 20650862150289 - case / 00650862150285- each Lot Number: ME231010
Distribution
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