Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0316-2024 — 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,

U.S. FDA — Device Enforcement · United States · 2023-09-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0316-2024
Date of alert: 2023-09-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Atrium Medical Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 20650862100017

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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