Atrium Medical Ocean Drains Recalled Due to Non-Sterile Outer Packaging
Atrium Medical is recalling Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
What this means for you
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. The hazard is a packaging sterility issue without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Atrium Medical Corporation is recalling specific Ocean Drains because 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 postoperative collection of autologous blood. The recall includes various Ocean single drain configurations, such as those with in-line connectors, suction control stopcocks, and pre-connected bags.
The recall covers all lot numbers with an expiration date prior to October 2019. A total of 964,463 cases were distributed in the United States, and 521,975 cases were distributed outside the US. The products were distributed worldwide, including in the US and numerous international locations such as Australia, Canada, China, France, Germany, and the United Kingdom.
Healthcare providers and facilities should stop using the affected Ocean Drains and contact Atrium Medical for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Surgical Drains
- Hazard
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.
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