Recall Z-1959-2014— Atrium Medical Corporation

Name: FDA recall Z-1959-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-28

Class II · Terminated

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2014-04-28, terminated 2016-03-17. It names 2 FDA 510(k) clearances: K043582, K043140. Product: Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.. 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..

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-04-28
Terminated: 2016-03-17
Firm location: Hudson, NH, United States

510(k) clearances named in this recall

2 on FDA's record

K043582 — OCEAN CHEST DRAINAtrium Medical Corp.·cleared 2005-01-21
K043140 — EXPRESS AND OASIS CHEST DRAINAtrium Medical Corp.·cleared 2004-12-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.