Atrium Medical Corporation recalls Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and

Recalled February 1, 2017 · FDA recall Z-1082-2017 · Atrium Medical

Hazard

Outer Packaging is not sterile · FDA Class II

Units

964,463 cases (US) 521,975 cases (OUS) in total

Sold at

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 Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,

Description

Outer Packaging is not sterile

Product

Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 2050-300 Ocean Blood Recovery drain with suction control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain with in-line connector and suction control stopcock - 2 patient lines connected by one Y connector 2052-300 Ocean Double Blood Recovery drain with suction control stopcock, no in-line connector - 2 patient lines connected by one Y connector 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.

Manufacturer(s)

Atrium Medical Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →