Atrium Medical Corporation recalls Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. t

Recalled February 1, 2017 · FDA recall Z-1084-2017 · 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 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.

Manufacturer(s)

Atrium Medical Corporation

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