Atrium Medical Recalls EXPRESS Dry Seal Chest Drains Due to Missing O-Ring
Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drains because they have a missing o-ring. The recall affects 390 cases distributed in the US, Canada, and Germany.
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 medical device with a structural defect (missing o-ring) that could compromise the device's function. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Atrium Medical Corporation is recalling EXPRESS Dry Seal Chest Drain, Single Collection (P/N: 4000-100N) because the devices have a missing o-ring. The recall involves 390 cases of the product.
The affected devices were distributed nationwide in the United States, as well as in Canada and Germany. The specific lot number for the recalled product is 222516.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drain
- Affected units
- 390
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)
- Lot Number: 222516
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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