Atrium Medical Corporation is recalling approximately 550,646 Ocean, Oasis, and Express chest drain units because the Instructions for Use (IFU) do not provide adequate precautions for setting up catheter and tube connections. Without clear instructions, healthcare providers may incorrectly set up these single collection chamber drains, which could lead to drainage issues for patients. This recall affects various models manufactured on or after July 21, 2020, and distributed worldwide, including over 547,000 cases in the United States. Patients and providers should contact their healthcare facility or the manufacturer to ensure proper setup procedures are followed.
Insufficient instruction for proper catheter and tube setup can lead to incorrect device configuration, potentially causing a failure to drain fluid or air from the patient's chest cavity. This could result in serious complications, such as a collapsed lung or tension pneumothorax, requiring medical intervention.
Manufacturer correction of Instructions for Use (IFU)
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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