Atrium Medical Oasis Dual Chamber Drain Recall Due to Sterility Issue
Atrium Medical is recalling Oasis dual chamber drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.
What this means for you
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 medical device where the outer packaging is not sterile, which poses a risk of infection or harm to patients. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are reported in the source text.
Plain-English summary
Atrium Medical Corporation is recalling its Oasis dual chamber drain with in-line connectors (2 Patient Tubes), product code 3620-100. The recall is being conducted because the outer packaging of the affected devices is not sterile. These medical devices are used to evacuate air and/or fluid from the chest cavity or mediastinum, help re-establish lung expansion, and facilitate postoperative collection and reinfusion of autologous blood.
The recall includes all lot numbers with an expiration date prior to October 2019. The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries such as Australia, Brazil, Canada, China, France, Germany, and the United Kingdom. The total quantity involved is 964,463 cases in the US and 521,975 cases outside the US.
Healthcare providers and facilities should stop using the affected Oasis dual chamber drains and contact Atrium Medical Corporation for instructions on how to return or dispose of the products. Patients who have had these devices implanted should contact their healthcare provider to discuss the recall and any necessary follow-up care.
The recalled product
- Product
- Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative coll
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Surgical Drains
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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