Maquet Express Dry Seal Suction OASIS DRAIN — Class II medical device recall Z-1211-2017
Terminated recall by Atrium Medical Corporation, reported 2017-02-22, distributed nationwide. Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after
| Recall number | Z-1211-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Hudson, NH, United States |
| Recall initiated | 2016-12-23 |
| Classified | 2017-02-15 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2020-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Reason classes | packaging |
| Lot numbers | 243312 |
Product
Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 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
Reason for recall
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1211-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.