Atrium Medical recalls Oasis Dry Suction Water Seal Chest Drains due to insufficient setup instructions for catheter connections, which could lead to improper patient tube connections.
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 two types of Oasis chest drains because their setup instructions don't adequately warn about proper catheter and patient tube connections. This could lead to improper connections that might cause injury.
The recall states that the instructions for use don't provide enough guidance for setting up the catheter and patient tube connections with single collection chamber chest drains. This could lead to improper connections that might cause injury.
Patients using these chest drains for medical treatment are most at risk. Healthcare providers who use the devices may also be affected.
Check for the model numbers 3600-100 DRAIN (OASIS SINGLE W/AC) or 3612-100 DRAIN (OASIS PEDI A/C) on the device. Products manufactured on or after July 21, 2020, and shipped on or after August 6, 2020 are affected.
Look for model numbers 3600-100 DRAIN or 3612-100 DRAIN on the device.
Reach out to Atrium Medical Corporation for specific guidance on safe use or replacement.
The instructions for use do not provide sufficient precautions for proper setup of catheter and patient tube connections with single collection chamber chest drains.
The affected models are 3600-100 DRAIN (OASIS SINGLE W/AC) and 3612-100 DRAIN (OASIS PEDI A/C).
No, but you should check the model and contact Atrium Medical for guidance on safe use or replacement.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0317-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-0317-2024 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.
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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.
