Atrium Medical Corporation 2023-11-22 Health serious FDA
Health · FDA · Recall #FDA-Z-0318-2024
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N… Recall
Issued November 22, 2023 · Atrium Medical Corporation
In November 2023, Atrium Medical Corporation recalled the Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Atrium Medical Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Atrium Medical Corporation
- Category
- Health
- Recall date
- November 22, 2023
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Brazil, Brunei Darussalam, Canad
- Recall number
- FDA-Z-0318-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Atrium Medical Corporation has 9 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.