Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall
Atrium Medical Corporation is recalling 1,002 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems due to potential tubing leaks or disconnections.
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 defect (leak/disconnect) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Atrium Medical Corporation is recalling 1,002 units of the Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System, Product Code 2052-300. The recall involves units with lot numbers ranging from 10883097 to 10913346, inclusive. These devices are used to evacuate air and/or fluid from the chest cavity or mediastinum.
The recall is being issued because the chest drain tubing of the ATS Blood Recovery System may leak or disconnect. This defect could compromise the function of the device during use.
The affected products were distributed worldwide, including the United States (nationwide), Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon, Netherlands, Jordan, Russia, and Taiwan. Healthcare facilities and users should check their inventory for the specific product code and lot numbers listed and stop using the affected units. Users should contact Atrium Medical Corporation for instructions on returning the devices or obtaining replacements.
The recalled product
- Product
- Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
- Manufacturer
- Atrium Medical Corporation
- Hazard
- Affected units
- 1,002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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