Atrium Medical Corporation recalls Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fl…

Recall date

October 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0582-2017

FDA classification

Class II

Brand / firm

Atrium Medical Corporation

Sold / distributed

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 A…

Why it was recalled

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.