Atrium Medical Corporation is recalling several lots of Atrium Oasis Dry Suction Water Seal Chest Drains, specifically models 3600-100 and 3650-100. These medical devices were re-processed and re-sterilized by an unauthorized third party using packaging and sterilization methods that were never approved or validated by the manufacturer. Because these processes were not verified for safety, the devices may not be sterile or could fail to function correctly during medical procedures. Healthcare facilities in Virginia should immediately check their inventory for the affected lot numbers and contact the manufacturer for guidance.
The use of these devices poses a risk of infection or device failure because the third-party sterilization process and packaging have not been proven to be effective or safe. This could lead to serious medical complications for patients who require chest drainage.
Unauthorized third-party re-processing and re-sterilization.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.