Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1080-2017·Announced 2017-02-01

Atrium Medical Recalls Dual Chamber Ocean Drains Due to Sterility Issues

Atrium Medical is recalling Dual Chamber Ocean Drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is typically associated with a temporary or medically reversible adverse health consequence. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is limited to the sterility of the outer packaging rather than the device itself.

Plain-English summary

Atrium Medical Corporation is recalling specific lots of Dual Chamber Ocean Drains. The recall is due to a defect where the outer packaging is not sterile. The affected products are used to evacuate air and fluid from the chest cavity or mediastinum, help re-establish lung expansion, and facilitate the collection and reinfusion of autologous blood.

The recall includes Ocean dual chamber drains with various configurations, including those with in-line connectors and suction control stopcocks. The specific product codes affected are 2020-000, 2020-100, and 2020-300. The recall covers all lot numbers with an expiration date prior to October 2019.

The affected products were distributed worldwide, including in the United States and numerous international markets. A total of 964,463 cases were distributed in the US and 521,975 cases outside the US. Healthcare facilities and distributors should stop using these products and contact Atrium Medical for instructions on return or replacement.

The recalled product

Product: Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes) 2020-100 Ocean dual chamber with in-line connectors and no suction control stopcock (2 Patient Tubes) 2020-300 Ocean dual…
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Surgical Drains
Hazard: sterility
infection-risk

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)

All Lot Numbers With Expiration Date Prior To October 2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 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.

See all 10 products in this recall →

Same manufacturer · Atrium Medical Corporation

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