Atrium Medical Recalls Maquet Ocean Water Seal Chest Drains
Atrium Medical Corporation is recalling Maquet Ocean Water Seal Chest Drains because the manual vent valve may fail to re-seal after use.
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 high-risk medical device where a mechanical failure (valve not re-sealing) poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity rating.
Plain-English summary
Atrium Medical Corporation is recalling 27 cases (162 units) of Maquet Ocean Water Seal Chest Drains, Single Collection w/AC (Reference: 2002-100). The affected units are identified by Lot Number 242897. These medical 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 may compromise the device's ability to maintain the necessary seal for safe patient use.
The affected products were distributed nationwide in the United States and internationally to Canada and Mexico. Healthcare providers and facilities should stop using the affected units and contact Atrium Medical Corporation for instructions on return or replacement.
The recalled product
- Product
- Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 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…
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drain
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: 242897
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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