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 390 cases distributed nationwide, in Canada, and in 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 defect (missing o-ring) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Atrium Medical Corporation is recalling 390 cases of Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000. The recall is due to a defect where the chest drains have a missing o-ring.
The affected product is identified by Lot Number 222511. The products were distributed nationwide in the United States, as well as in Canada and Germany.
Consumers and healthcare providers should stop using the affected chest drains and contact Atrium Medical Corporation for further instructions on how to proceed.
The recalled product
- Product
- Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drain
- Hazard
- 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: 222511
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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