FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
- Recall number
- Z-1959-2014
- Recalling firm
- Atrium Medical Corporation
- Product
- Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
- Status
- Terminated
- Initiated
- 2014-04-28
- Posted
- 2014-07-01
- Terminated
- 2016-03-17
- Reason
- Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.
- Root cause
- Nonconforming Material/Component
- Action
- Smith & Nephew notified Distributors on April 28, 2014 by telephone. A follow up e-mail and a recall notification letter were issued by UPS on 6/27/14. Distributors were requested to notify customers who received the lot. A reply acknowledgement form was to be completed and returned. Return Goods Authorizations for the return of the goods were issued to customers.
- Quantity
- 195 Cases; Total 1170 units
- Distribution
- Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
- Lot, serial or model codes
- Lot Number: 10906458
- 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