Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall
Atrium Medical Corporation is recalling Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.
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 (leak or disconnect) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Atrium Medical Corporation is recalling the Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors. The recall involves 10,448 units of the device, which is 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. The affected units are identified by lot numbers starting with 10883097 and ending with 10913346, including all units in between.
The affected products were distributed nationwide in the United States as well as in Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon, Netherlands, Jordan, Russia, and Taiwan. Users should contact Atrium Medical Corporation for further instructions regarding the recall.
The recalled product
- Product
- Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
- Manufacturer
- Atrium Medical Corporation
- Hazard
- Affected units
- 10,448
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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