Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis… — Class II medical device recall Z-1086-2017
Terminated recall by Atrium Medical Corporation, reported 2017-02-01, distributed nationwide. Outer Packaging is not sterile
| Recall number | Z-1086-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Hudson, NH, United States |
| Recall initiated | 2016-11-29 |
| Classified | 2017-01-24 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2020-09-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CL, CN, DE, DZ, EC, EG, ES, FI, FR, GB, GR, GT, HK, IE, IT, KR, KW, LB, MX, NL, NZ, PA, PE, PK, PL, PT, SA, SE, TH, TN, VE |
| Reason classes | sterility |
Product
Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: 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 patient s pleural cavity or mediastinal area.
Reason for recall
Outer Packaging is not sterile
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-1086-2017. 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.