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Atrium Medical Corporation recalls Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector
Recalled February 1, 2017 · FDA recall Z-1087-2017 · 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 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.
Manufacturer(s)
Atrium Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →