Atrium Express Dry Seal Chest Drain with Sterile Fluid Path… recallZ-0500-2007 · Atrium Medical Corporation · initiated Nov 8, 2006
Terminated All recalls posted in February 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Atrium Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Chest drainage tubing incorrectly assembled and may disconnect from patient during use
FDA root cause category: Other
What the company is doing
Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned.
Recall details
- Recall number
- Z-0500-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 8, 2006
- Posted by the FDA
- Feb 15, 2007
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 49 cases ( 294 units)
- Product code
- CAC
- FDA submissions
- K043140
- Distribution
- Nationwide, including CA, and PA.
Product description
Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
Code information (models, lots, serial numbers)
Lot Numbers; 10137320, 10116878, 10101974
Other devices under the same FDA submission
3 devices cleared under K043140 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- OASIS 3620-100Atrium Medical Corporation · Bottle, Collection, Vacuum51 reports
- OASIS 3612-400Atrium Medical Corporation · Bottle, Collection, Vacuum3 reports
- OASIS 3600-150Atrium Medical Corporation · APPARATUS, AUTOTRANSFUSION1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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