Atrium Medical Corporation recalls Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4…

Recall date

November 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1087-2017

FDA classification

Class II

Brand / firm

Atrium Medical Corporation

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Ze…

Why it was recalled

Outer Packaging is not sterile

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express PreFilled Chest Drain 4020-100N Express dual chamber drain with in-line connectors ( 2 Patient Tubes) 4050-100N Express Blood Recovery drain with in-line connector 4050-100P Express PreFilled Chest Drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help re-establish lung expansion and restore breathing dynamics.  To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.