Atrium Medical Oasis Single Drain Recalled for Non-Sterile Packaging
Atrium Medical is recalling Oasis Single Drains because the outer packaging is not sterile, posing a risk of infection.
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 3/5 (High).
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 with a risk of harm (infection) due to non-sterile packaging, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Atrium Medical Corporation is recalling Oasis Single Drains, including models 3600-100 and 3600-150, due to a defect in the outer packaging. The recall affects all lot numbers with expiration dates prior to October 2019.
The recall was initiated because the outer packaging is not sterile. These medical devices are used to evacuate air and fluid from the chest cavity or mediastinum, and to help re-establish lung expansion. The non-sterile packaging presents a risk of infection to patients.
The recall covers approximately 964,463 cases in the United States and 521,975 cases outside the US, with distribution in numerous countries worldwide. Healthcare facilities and distributors should stop using the affected devices and contact Atrium Medical for instructions on return or replacement.
The recalled product
- Product
- Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-line connector and Pre-connected 2550 ATS Bag Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help…
- 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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