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Recall Observatory FDA recall evidence

Device 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.

Z-0582-2017

October 26, 2016

Class II

Product summary

Firm
Atrium Medical Corporation
Event
Event 75347
Status
Terminated
Classification
Class II
Quantity
7043 cases (10/cs)
Official record key
device-enforcement:Z-0582-2017

Official wording

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

Code information: All lot codes

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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