Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
FDA device recall Z-0500-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- Chest drainage tubing incorrectly assembled and may disconnect from patient during use
- Action taken
- Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 49 cases ( 294 units)
- Distribution
- Nationwide, including CA, and PA.
- Date initiated
- 2006-11-08
- Date posted
- 2007-02-15
- Date terminated
- 2007-11-27
- Location
- Hudson, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPRESS AND OASIS CHEST DRAIN (K043140) | Atrium Medical Corp. | 2004-12-08 |