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Atrium Medical Corporation recalls Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and
Recalled November 23, 2016 · FDA recall Z-0582-2017 · Atrium Medical
Hazard
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. · FDA Class II
Units
7043 cases (10/cs)
Sold at
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.
Description
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Product
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.
Manufacturer(s)
Atrium Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →