Device product
Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Z-0578-2017
Product summary
- Event
- Event 75347
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2697 cases (10/cs)
- Official record key
device-enforcement:Z-0578-2017
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
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.