FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
- Recall number
- Z-0500-2007
- Recalling firm
- Atrium Medical Corporation
- Product
- Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N
- Status
- Terminated
- Initiated
- 2006-11-08
- Posted
- 2007-02-15
- Terminated
- 2007-11-27
- Reason
- Chest drainage tubing incorrectly assembled and may disconnect from patient during use
- Root cause
- Other
- Action
- Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned.
- Quantity
- 49 cases ( 294 units)
- Distribution
- Nationwide, including CA, and PA.
- Lot, serial or model codes
- Lot Numbers; 10137320, 10116878, 10101974
- 510(k) numbers
- ["K043140"]
- PMA numbers
- not on file
- Product code
- CAC
- Firm FEI
- 3011175548
- Firm city
- Hudson
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28