FDA-Device2017-02-01Class II

Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of 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

Atrium Medical Corporation
Hazard

Outer Packaging is not sterile

Sold states
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,
Affected count
964,463 cases (US) 521,975 cases (OUS) in total
Manufactured in
5 Wentworth Dr, N/A, Hudson, NH, United States
Products
Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1084-2017

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