Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis… — Class II medical device recall Z-1084-2017
Terminated recall by Atrium Medical Corporation, reported 2017-02-01, distributed nationwide. Outer Packaging is not sterile
| Recall number | Z-1084-2017 |
|---|---|
| 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 Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 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.