Atrium Medical Recalls Oasis Chest Drains Due to Missing O-Ring
Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal Chest Drains because they have a missing o-ring. The recall covers 1,170 cases distributed nationwide and in Canada and Germany.
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 is classified as FDA Class II. The hazard involves a missing o-ring in a chest drain, which is a risk-of-harm product where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Atrium Medical Corporation is recalling 1,170 cases of Oasis Dry Suction Water Seal Chest Drains, DRY SINGLE W/AC, P/N: 3600-100. The recall was initiated because the devices have a missing o-ring. The affected lot numbers are 222115, 222118, and 222528.
The recalled products were distributed nationwide in the United States, as well as in Canada and Germany. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and facilities should stop using the affected devices and contact Atrium Medical Corporation for instructions on how to return or dispose of them. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drain
- Affected units
- 1,170
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 (3)
- Lot Numbers: 222115
- 222118
- 222528
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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