Atrium Medical Recalls Maquet Express Dry Seal Suction OCEAN DRAIN Chest Drains
Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction OCEAN DRAIN 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 potential failure of a medical device to re-seal, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE (Reference: 2002-400) chest drains. The recall involves Lot Number 243842, distributed in cases of 6 units. 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.
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 intended seal during use.
The affected units were distributed worldwide, including nationwide in the United States and internationally to Canada and Mexico. Healthcare facilities and users should stop using the affected chest drains and contact Atrium Medical Corporation for instructions on return or replacement.
The recalled product
- Product
- Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 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
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: 243842
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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