FDA-Device2016-11-23Class II
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Atrium Medical Corporation
Hazard
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Sold states
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
Affected count
2172 cases (10/cs)
Manufactured in
5 Wentworth Dr, N/A, Hudson, NH, United States
Products
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0579-2017Don't want to check this manually?
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