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

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 incorporate — recall Z-0307-2022

U.S. FDA — Device Enforcement · United States · 2021-10-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0307-2022
Date of alert: 2021-10-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Atrium Medical Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00650862100211

Reported risk: Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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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