Atrium Medical Oasis Pediatric Drain Recalled for Non-Sterile Packaging
Atrium Medical is recalling Oasis Pediatric Drains because the outer packaging is not sterile. The recall covers 964,463 US cases and 521,975 international cases.
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 2/5 (Moderate).
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, and the hazard is a packaging sterility issue without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Atrium Medical Corporation is recalling Oasis Pediatric Drains, including models 3612-100 and 3612-400, because the outer packaging is not sterile. These medical devices are used to evacuate air and fluid from the chest cavity or mediastinum, help re-establish lung expansion, and facilitate postoperative blood collection.
The recall affects 964,463 cases in the United States and 521,975 cases in other countries, with worldwide distribution across numerous nations. The affected units are identified by all lot numbers with expiration dates prior to October 2019.
Healthcare facilities and consumers should stop using these devices and contact Atrium Medical Corporation for instructions on return or replacement.
The recalled product
- Product
- Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector…
- 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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