Atrium Medical Recalls 28Fr Thoracic Catheters Due to Seal Defect
Atrium Medical Corporation is recalling 2,930 units of 28Fr PVC Thoracic Catheters due to a seal defect in sterile barrier pouches that could compromise sterility.
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 3/5 (High).
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: The recall involves a risk-of-harm product (sterility breach in a critical anatomical structure) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Atrium Medical Corporation is recalling 2,930 units of the Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE (Part No. 8128). The recall was initiated because a seal defect was found in certain sterile barrier pouches containing the device, leaving the bottom of the pouch un-sealed.
The affected devices are used in contact with critical anatomical structures and deep within the body. If the pouch defect is not detected, a sterility breach could lead to product contamination. The source text notes that the severity of potential clinical complications depends on the degree of contamination, the microorganisms involved, and patient risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.
The recall covers units distributed worldwide, including US nationwide distribution and the country of Saudi Arabia. The specific lot code associated with this recall is ME221275.
The recalled product
- Product
- Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Catheter
- Affected units
- 2,930
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)
- ME221275
Distribution
Distributed nationwide across the United States.
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