FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
- Recall number
- Z-0735-2014
- Recalling firm
- Atrium Medical Corporation
- Product
- Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
- Status
- Terminated
- Initiated
- 2013-11-19
- Posted
- 2014-01-14
- Terminated
- 2015-06-11
- Reason
- Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
- Root cause
- Device Design
- Action
- Atrium Medical issued notification letters to direct consignees by UPS next day on 19 November 2013, and indirect consignees (distributors customers) by UPS next day or USPS priority (for customers with a PO Box) on 27 November 2013. The Letter explain the issue and the steps that should be taken. The customer will be offered replacement with unaffected product or credit. The firm describes Procedures for Emergency Use. The firm identifies potential product substitutions. These products are the same drainage product without the auto-transfusion line. International Distributors. International distributors provided with the Recall Authorization' package and the customer letter. Accounts are requested to complete the Recall Reply Form acknowledging receipt of the notification. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm.
- Quantity
- 10,448 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
- Lot, serial or model codes
- Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
- 510(k) numbers
- ["K043140","K043582"]
- 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