Recalls / —
—#49575
Product
Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
- FDA product code
- CAC — Apparatus, Autotransfusion
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K043140
- Affected lot / code info
- Lot Numbers; 10137320, 10116878, 10101974
Why it was recalled
Chest drainage tubing incorrectly assembled and may disconnect from patient during use
Root cause (FDA determination)
Other
Action the firm took
Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned.
Recalling firm
- Firm
- Atrium Medical Corporation
- Address
- 5 Wentworth Dr, Hudson, New Hampshire 03051-4929
Distribution
- Distribution pattern
- Nationwide, including CA, and PA.
Timeline
- Recall initiated
- 2006-11-08
- Posted by FDA
- 2007-02-15
- Terminated
- 2007-11-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #49575. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.