Ocean Water Seal Chest Drains — Class II medical device recall Z-0316-2024
Ongoing recall by Atrium Medical Corporation, reported 2023-11-22, distributed nationwide. Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient pre
| Recall number | Z-0316-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2023-09-18 |
| Classified | 2023-11-16 |
| Reported by FDA | 2023-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CL, CN, CZ, DE, DZ, EC, EG, ES, FI, FR, GB, HK, ID, IE, IL, IS, IT, JO, KR, KW, LT, LU, LV, MT, MX, MY, NL, NO, NZ, PE, PK, PL, PT, QA, SA, SE, SG, SI, TH, TN, TW, UA, UY, ZA |
| UPC / GTIN / UDI-DI | 20650862100017, 20650862100093, 20650862100109, 20650862100215, 20650862100345, 20650862101021, 20650862103018 |
Product
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,S
Reason for recall
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
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-0316-2024. 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.