FDAClass IINovember 23, 2022

Atrium Ocean Wet Suction Water Seal Chest Drain recall

Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000

Why was Atrium Ocean Wet Suction Water Seal Chest Drain recalled?

Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226

Product
Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Recalling firm
Atrium Medical Corporation
Quantity
24 units (4cases/6)
Distribution
US Nationwide distribution in the state of VA.
Recall date
November 23, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls