OCEAN recallZ-0235-2023 · Atrium Medical Corporation · initiated Oct 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Atrium Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
FDA root cause category: Storage
What the company is doing
Atrium/ Getinge issued Urgent Medical Device Removal on 10/18/21 via email with Delivery and Read receipt. Letter states reason for recall, health risk and action to take: Our records indicate that McKesson has received the Atrium Ocean Wet Suction Water Seal Chest Drains from the lot listed on Page 1. " Please examine your inventory and confirm that you have no remaining Atrium Ocean Wet Suction Water Seal Chest Drain 2002-000 with the REF/LOT number listed in this notice. Please return any product that may be affected under this Field Action. " Please respond to this email using the response form on page 3 to acknowledge that you have received this notification. If you have any questions, please contact your Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Recall details
- Recall number
- Z-0235-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 18, 2022
- Posted by the FDA
- Nov 15, 2022
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 24 units (4cases/6)
- Product code
- KDQ
- FDA submissions
- K043582
- Distribution
- US Nationwide distribution in the state of VA.
Product description
Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Code information (models, lots, serial numbers)
UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OCEAN 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 reports
Product lines
Other devices under the same FDA submission
8 devices cleared under K043582 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- OCEAN 2002-400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM2 recalls18 reports
- OCEAN 2002-300Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall10 reports
- OCEAN 2012-320Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall3 reports
- OCEAN 2002-100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall0 reports
- OCEAN 2002-040Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall0 reports
- OCEAN 2020-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM32 reports
- OCEAN 2020-100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 report
- OCEAN 2050-300Atrium Medical Corporation · Apparatus, Autotransfusion1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page