Atrium Medical Corporation recalls Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopco…

Recall date

November 29, 2016

Source

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

Recall number

Z-1079-2017

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 Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with in-line connector and suction control stopcock, Pre-connected 2550 ATS Bag 2002-100 Ocean single drain with in-line connector, no suction control stopcock 2002-300 Ocean single drain with suction control stopcock, no in-line connector 2002-400 Ocean single drain, no in-line connector or suction control stopcock, Water ampoule 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.