Class II — Atrium Medical Corporation
| Recalling firm | ATRIUM MEDICAL CORPORATION |
|---|---|
| Registered facility | Atrium Medical Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| Product | Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. |
| Quantity | 4836 cases (10/cs) |
| Distribution | 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. |
| Initiated | 2016-10-26 |
| Classified | 2016-11-16 |
| Terminated | 2018-10-09 |
| Recall number | Z-0580-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Atrium Medical Corporation (Z-0580-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75347/
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