Atrium Medical recalls Ocean Water Seal Chest Drains due to insufficient instructions for proper setup of catheter connections, which could lead to improper use. Affected models include Ocean Single W/AC, Pedi Connectors, and others manufactured from July 21, 2020 onward.
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
Atrium Medical is recalling Ocean Water Seal Chest Drains because the instructions for use don't adequately explain how to properly set up the catheter connections and patient tubes. This could lead to improper use if the device isn't assembled correctly, potentially causing complications for patients.
The recall is due to insufficient instructions for setting up the catheter connections and patient tube connections with single collection chamber chest drains. If not assembled correctly, this could lead to improper drainage or other complications during medical procedures.
Patients using Ocean Water Seal Chest Drains for medical procedures are most at risk. Healthcare providers who have these devices in their inventory or are using them for treatments may also be affected.
Check for the product model numbers listed in the recall: Ocean Single W/AC, Pedi Connectors, and others. These were manufactured on or after July 21, 2020, and shipped on or after August 6, 2020.
Review the product model number and manufacturing date to confirm if it matches the recalled items listed in the notice.
Reach out to Atrium Medical Corporation for guidance on proper setup and potential remedies if the device is affected.
The affected models include Ocean Single W/AC, Pedi Connectors, and others with product numbers starting with 2002-000, 2002-040, 2002-100, 2002-300, 2002-400, 2012-320, and 2050-000.
Products were manufactured on or after July 21, 2020, and shipped on or after August 6, 2020.
No, but you should check if your device is affected and follow the manufacturer's instructions for proper setup to avoid potential complications.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0316-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-0316-2024 from Atrium Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
