Atrium Medical Corporation: Medical Device Recall in 2016 - (Recall #: Z-0582-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 26, 2016

Date Posted: November 23, 2016

Recall Number: Z-0582-2017

Event ID: 75347

Reason for Recall:

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

Status: Terminated

Product Quantity: 7043 cases (10/cs)

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.

Voluntary or Mandated:

Voluntary: Firm initiated