OCEAN recallZ-0307-2022 · Atrium Medical Corporation · initiated Oct 22, 2021
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
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
FDA root cause category: Labeling design
What the company is doing
Atrium/Getinge issued Urgent Medical Device Correction letter issued October 22, 2021 via FedEx 2 day delivery. Letter states reason for recall, health risk and action to take: Our records indicate that you have received the Ocean Water Seal Chest Drain, Product Code/REF number 2002-400, having the lot numbers that are affected by this correction. Please ensure that all Ocean Water Seal Chest Drain, Product Code/REF number 2002-400, users at your facility are aware of this notice and post a copy of the Product Correction Notification on Page 4 in all inventory locations within your facility where the Atrium Ocean Chest Drains are stored. Please examine your inventory immediately to determine if you have any of the Ocean Water Seal Chest Drain, Product Code/REF number 2002-400, with the lot numbers listed in this notice. PLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL OCEAN CHEST DRAIN USERS WITHIN YOUR HOSPITAL / FACILITY. IF YOU ARE A DISTRIBUTOR WHO HAS SHIPPED ANY AFFECTED PRODUCTS TO CUSTOMERS, PLEASE FORWARD THIS DOCUMENT TO THEIR ATTENTION FOR APPROPRIATE ACTION. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5) to acknowledge that you have received this notification. Return the completed form to Atrium/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to (877) 448-0547. f you have any questions, please contact your Atrium/Getinge representative or call 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-0307-2022
- Status
- Open, Classified
- Initiated by the company
- Oct 22, 2021
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 87,972 drains (14,662 cases; 6 units/case)
- Product code
- KDQ
- FDA submissions
- K043582
- Distribution
- US Nationwide Distribution Foreign: Bahrain Belgium Brunei Darussalam Canada Colombia Ecuador Finland Italy Kuwait Libya Mauritius Mexico Netherlands Poland Portugal Russian Federation Saudi Arabia Spain United Arab Emirates United Kingdom of Great Britain and Northern Ireland
Product description
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.
Code information (models, lots, serial numbers)
Product Code/REF Number 2002-400; Lot codes: 441533, 443300, 443608, 443629, 444473, 445527, 448966, 449683, 450899, 450900, 451270, 451988, 452177, 452814, 454577, 455871, 458264, 458604, 459198, 459642, 462192, 462194, 464075, 464076, 465037, 466247, 469921, 470627, 471651,471703, 472562, 472785 and 473725. UDI Code: 00650862100211
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OCEAN 2002-400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM2 recalls18 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 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 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