Atrium Medical Recalls Maquet Ocean Water Seal Chest Drains
Atrium Medical is recalling Maquet Ocean Water Seal Chest Drains because the manual vent valve may fail to re-seal after being depressed.
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: The recall is classified as FDA Class II, and the hazard involves a medical device defect that could compromise patient safety without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Atrium Medical Corporation is recalling 245 cases (1,470 units) of Maquet Ocean Water Seal Chest Drains, Single Collection WAC (Reference: 2002-000). The affected products are identified by Lot Numbers 242896 and 243292. These devices are intended to evacuate air and/or fluid from the chest cavity or mediastinum to help re-establish lung expansion and restore breathing dynamics.
The recall was initiated because the manual vent valve located at the top of the affected chest drains could potentially not re-seal after being depressed. This defect could compromise the device's ability to maintain the intended water seal.
The affected units were distributed nationwide in the United States, as well as internationally to Canada and Mexico. Users of these devices should contact Atrium Medical Corporation for instructions on how to proceed.
The recalled product
- Product
- Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and r
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drain
- Hazard
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 (2)
- Lot Number: 242896
- 243292
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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