Atrium Medical Recalls Maquet Oasis Chest Drains Due to Valve Defect
Atrium Medical is recalling Maquet Oasis 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 is classified as FDA Class II, and the hazard involves a medical device failure that could compromise patient safety, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Atrium Medical Corporation is recalling the Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC (Reference: 3600-100). The recall involves 2,933 cases, totaling 17,598 units, distributed nationwide in the United States and internationally to Canada and Mexico.
The recall is being issued because the manual vent valve located at the top of the affected chest drains could potentially not re-seal after being depressed. The product is intended to evacuate air and/or fluid from the chest cavity or mediastinum to help re-establish lung expansion and restore breathing dynamics.
Affected units are identified by Lot Numbers 242909, 242910, 242912, 242914, and 242915. Healthcare facilities and consumers should check their inventory for these specific lot numbers and contact Atrium Medical Corporation for instructions on how to return the product.
The recalled product
- Product
- Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 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…
- Manufacturer
- Atrium Medical Corporation
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 (5)
- Lot Number: 242909
- 242910
- 242912
- 242914
- 242915
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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