Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain — Class II medical device recall Z-1079-2017
Terminated recall by Atrium Medical Corporation, reported 2017-02-01, distributed nationwide. Outer Packaging is not sterile
| Recall number | Z-1079-2017 |
|---|---|
| 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 Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with in-line connector and suction control stopcock, Pre-connected 2550 ATS Bag 2002-100 Ocean single drain with in-line connector, no suction control stopcock 2002-300 Ocean single drain with suction control stopcock, no in-line connector 2002-400 Ocean single drain, no in-line connector or suction control stopcock, Water ampoule 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
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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.