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Use caution Medical device recall · FDA · Published September 18, 2023

Atrium Express Dry Seal Chest Drains: Inadequate Setup Instructions Risk

Atrium Medical recalls Express Dry Seal Chest Drains with insufficient setup instructions for catheter connections, potentially causing improper patient tube connections. Affected models include 4000-100N DRAIN and 4050-100N DRAIN, manufactured from July 21, 2020 onward.

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

🇺🇸 FDA recall #Z-0318-2024Medical deviceAtrium Medical ›
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Contact the company

Recalling firmAtrium Medical Corporation40 Continental Blvd · Merrimack, NH 03054-4332
✎ GovInfoNow plain-language explainer

Atrium Medical is recalling Express Dry Seal Chest Drains due to inadequate instructions for setting up catheter connections. This could lead to improper patient tube connections if not followed correctly. The recall affects specific models manufactured from July 21, 2020. Read more at govinfonow.com/recall/57305-atrium-express-dry-seal-chest-drains-inadequate-setup-instructions-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57305-atrium-express-dry-seal-chest-drains-inadequate-setup-instructions-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0318-2024

Cite this page

“Atrium Express Dry Seal Chest Drains: Inadequate Setup Instructions Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57305-atrium-express-dry-seal-chest-drains-inadequate-setup-instructions-risk. Based on FDA recall #Z-0318-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0318-2024%22&limit=1).

The FDA announced on September 18, 2023, that Atrium Medical Corporation is recalling Express Dry Seal Chest Drains due to insufficient setup instructions. The agency issued recall number Z-0318-2024 for the Class II voluntary recall.

How to tell if you have it

  • Brand: Atrium Medical
  • Product: Express Dry Seal Chest Drains (Express)
  • Model: 4000-100N DRAIN, EXPRESS, SINGLE
  • Model: 4050-100N DRAIN, EXPRESS, BRU
  • Lot/UDI: 20650862115134 (4000-100N)
  • Lot/UDI: 20650862115141 (4050-100N)
  • Manufacturing Date: On and after July 21, 2020
  • Distribution Date: On and after August 6, 2020

The hazard

According to the FDA, the Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instructions for proper setup of catheters and patient tube connections with single collection chamber chest drains.

Context

GovInfoNow's records show Atrium Medical Corporation has 16 other recalls on record since November 22, 2017. Other recent recalls include a Getinge Thoracic Catheter recall regarding bacterial endotoxin testing issues (August 7, 2026) and an Atrium Medical iCast Stent recall for UDI label errors (September 9, 2024). Similar recent recalls of catheter products include Medline Medical Procedure Kit recalls for catheter issues (May 4, 2026) and a Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray recall for erroneous safety indicator risk (November 6, 2025).

How to tell if you have this one

Check for the model numbers 4000-100N DRAIN, EXPRESS, SINGLE or 4050-100N DRAIN, EXPRESS, BRU on the device. These products were manufactured on or after July 21, 2020 and shipped on or after August 6, 2020.

  • Brand
    Atrium Medical
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Korea, Republic of Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Norway, Pakistan, Peru, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan Province of China, Thailand Tunisia, Ukraine, United Arab Emirates, United Kingdom, Uruguay.
Recall numberProduct, codes & lotsQuantity
Z-0316-2024Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,S; 1)2002-000 DRAIN, OCEAN SINGLE W/AC,S 20650862100017 (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR 20650862100345 (3)2002-100 DRAIN, OCEAN SINGLE W/AC 20650862100093 (4)2002-300 DRAIN, OCEAN SINGLE W/S 20650862100109 (5) 2002-400 DRAIN, OCEAN SINGLE 20650862100215 (6)2012-320 DRAIN, OCEAN PEDI W/S 20650862101021 (7)2050-000 DRAIN, OCEAN BRU W/AC,S 20650862103018 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 202031270 cases: 29942 cases US; 1328 cases OUS
Z-0317-2024Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;; UDI-DI: (1)3600-100 DRAIN, OASIS SINGLE W/AC 20650862110016; (2)3612-100 DRAIN, OASIS PEDI A/C 20650862111013; (3) 3650-100 DRAIN, OASIS BRU W/AC 20650862113017 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020471037 cases US; 638 case OUS
Z-0318-2024Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU; UDI-DI: (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134; (2) 4050-100N DRAIN, EXPRESS, BRU 20650862115141 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 202048339 cases: 48148 cases US; 193 cases OUS
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model numbers 4000-100N DRAIN, EXPRESS, SINGLE or 4050-100N DRAIN, EXPRESS, BRU on the device.

  2. Review Instructions

    Ensure you have the complete instructions for use to properly set up catheter connections and patient tube connections.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland,…” 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 2 months after the firm started it.

1. Firm started the recall: Sep 18, 202312. FDA classified it Class II: Nov 16, 202323. Published in FDA’s Enforcement Report: Nov 22, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-0318-2024 (September 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0318-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA