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 | Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. |
| Product | Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area |
| Quantity | 681 cases (4086 units) |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico |
| Initiated | 2016-12-23 |
| Classified | 2017-02-15 |
| Terminated | 2020-11-03 |
| Recall number | Z-1208-2017 |
| 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-1208-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75707/
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