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.
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 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.
The recall states that the instructions for use do not provide enough guidance for properly setting up catheter connections and patient tube connections with single collection chamber chest drains. This could lead to improper connections that might cause complications for patients.
Healthcare professionals using the Express Dry Seal Chest Drains for patient care are most at risk. Patients receiving treatment with these devices may be affected if improper setup occurs.
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.
Look for the model numbers 4000-100N DRAIN, EXPRESS, SINGLE or 4050-100N DRAIN, EXPRESS, BRU on the device.
Ensure you have the complete instructions for use to properly set up catheter connections and patient tube connections.
The affected models are 4000-100N DRAIN, EXPRESS, SINGLE and 4050-100N DRAIN, EXPRESS, BRU.
These products were manufactured on or after July 21, 2020.
No, but you should review the 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-0318-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-0318-2024 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.
