Atrium Medical Recalls Maquet Express Dry Seal Suction OASIS Drain
Atrium Medical Corporation is recalling 18 units of Maquet Express Dry Seal Suction OASIS Drain because the manual vent valve may fail to re-seal.
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. The hazard involves a medical device failure that could compromise patient treatment, but the source text does not report any specific 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 18 units (3 cases) of Maquet Express Dry Seal Suction OASIS Drain, Reference 3612-100, Lot Number 243312. The affected 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 is due to a defect where the manual vent valve located at the top of the chest drain could potentially not re-seal after being depressed. This failure could compromise the device's ability to maintain the required seal for patient treatment.
The affected units were distributed nationwide in the United States and internationally to Canada and Mexico. Healthcare providers and facilities should stop using the affected devices and contact Atrium Medical Corporation for further instructions.
The recalled product
- Product
- Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 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 re
- 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: 243312
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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