Use caution Medical device recall · FDA · Published October 22, 2021

Atrium Medical Ocean Water Seal Chest Drain Recall: Inadequate Setup Risk

Atrium Medical recalls Ocean Water Seal Chest Drain devices due to unclear setup instructions that may delay treatment and cause patient harm. Affected units have specific lot codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0307-2022Medical device Atrium Medical ›

Use caution until it’s fixed

Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient

Take action

Contact the company

Recalling firmAtrium Medical Corporation40 Continental Blvd · Merrimack, NH 03054-4332

✎ GovInfoNow plain-language explainer

Atrium Medical is recalling their Ocean Water Seal Chest Drain devices because the setup instructions are unclear, which could delay treatment and cause patient harm. This is a medical device used for chest drainage in hospitals and clinics. Read more at govinfonow.com/recall/61633-atrium-medical-ocean-water-seal-chest-drain-recall-inadequate-setup.

Source Summary by GovInfoNow · govinfonow.com/recall/61633-atrium-medical-ocean-water-seal-chest-drain-recall-inadequate-setup · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0307-2022

Cite this page

“Atrium Medical Ocean Water Seal Chest Drain Recall: Inadequate Setup Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61633-atrium-medical-ocean-water-seal-chest-drain-recall-inadequate-setup. Based on FDA recall #Z-0307-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0307-2022%22&limit=1).

Atrium Medical Corporation recalled The Ocean Water Seal Chest Drain due to inadequate setup instructions that may delay treatment and harm patients, the FDA said on Oct. 22, 2021.

How to tell if you have it

Brand: Atrium Medical
Product: The Ocean Water Seal Chest Drain
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

The hazard

The recall involves inadequate or inappropriate setup instructions for the plastic, three-bottle vacuum collection device, which may result in a delay in treatment and an unreasonable risk of harm to the patient.

Context

GovInfoNow's records show Atrium Medical Corporation has had 16 other recalls on record since Nov. 22, 2017. Other recent recalls include a Getinge Thoracic Catheter recall for bacterial endotoxin testing issues (Aug. 7, 2026), an Atrium Medical iCast Stent recall for UDI label errors (Sept. 9, 2024), and an Atrium Medical ADVANTA VXT Vascular Graft recall for slider separation risk (May 3, 2024). Other recent recalls of similar products include a Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray recall for erroneous safety indicator risk (Nov. 6, 2025), Cardinal Health Chest Drainage Units for risk of incorrect use in infants (Dec. 26, 2025), and a Medtronic DLP Retrograde Cannula recall for sterile barrier breach risk (April 21, 2026).

How to tell if you have this one

Check for 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, 473725. The device is a plastic three-bottle vacuum collection system used for chest drainage.

Brand
Atrium Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Code
Look for lot codes listed in the recall notice: 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, 473725.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 40 days after the firm started it.

Oct 22, 2021Firm started the recall
Nov 25, 2021FDA classified it Class II
Dec 1, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Atrium Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/61633-atrium-medical-ocean-water-seal-chest-drain-recall-inadequate-setup">Atrium Medical Ocean Water Seal Chest Drain Recall: Inadequate Setup Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0307-2022 (October 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0307-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.