The Ocean Water Seal Chest Drain is a plastic — Class II medical device recall Z-0307-2022
Ongoing recall by Atrium Medical Corporation, reported 2021-12-01, distributed nationwide. Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk
| Recall number | Z-0307-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2021-10-22 |
| Classified | 2021-11-25 |
| Reported by FDA | 2021-12-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, BH, CA, CO, EC, ES, FI, GB, IE, IT, KW, MX, NL, PL, PT, SA |
| UPC / GTIN / UDI-DI | 00650862100211 |
| Lot numbers | 441533, 443300, 443608, 443629, 444473, 445527, 448966, 449683, 450899, 450900, 451270, 451988, 452177, 452814, 454577, 455871, 458264, 458604, 459198, 459642, 462192, 462194, 464075, 464076, 465037, 466247, 469921, 470627, 471651, 471703, 472562, 472785, 473725 |
| Model numbers | 2002-400 |
Product
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.
Reason for recall
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
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-0307-2022. 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.