Atrium Ocean Wet Suction Chest Drains recalled due to storage temperature excursions
Atrium Medical Corporation is recalling Atrium Ocean Wet Suction Water Seal Chest Drains (Product Code 2002-000) distributed in the United States due to warehouse temperature excursions in July and August 2021. No patient harm has been reported.
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: This is a FDA Class II medical device recall with no reported patient injury or illness. The recall is precautionary in nature, addressing warehouse storage conditions that did not result in documented patient impact.
Plain-English summary
Atrium Medical Corporation is recalling Atrium Ocean Wet Suction Water Seal Chest Drains (Product Code 2002-000) distributed in the United States. The affected product lot numbers are 472326 and 473226.
The product was subject to warehouse temperature excursions in July and August 2021. The FDA investigated and determined that no patient harms were associated with these temperature excursions.
The recalled product
- Product
- Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drainage
- Hazard
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 (2)
- UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326
- 473226
Distribution
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