Atrium Medical Recalls Ocean Water Seal Chest Drains Due to Missing O-Ring
Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 130 cases distributed nationwide and in 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) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains, Single W/AC, P/N: 2002-100. The recall involves 130 cases of the product. The distribution pattern includes nationwide distribution in the United States, as well as Canada and Germany. The specific lot number is 222945.
The reason for the recall is that the chest drains have a missing o-ring. The source text does not provide further details on the specific consequences of the missing component or any reported injuries.
Consumers and healthcare facilities should check their inventory for this specific product and lot number. If the product is found, it should be removed from use and returned to the supplier or the manufacturer according to their instructions.
The recalled product
- Product
- Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drain
- Hazard
- Affected units
- 130
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: 222945
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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