Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: ...

FDA Recall #Z-1205-2017 — Class II — December 23, 2016

Recall #Z-1205-2017 Date: December 23, 2016 Classification: Class II Status: Terminated

Product Description

Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: 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 patients pleural cavity or mediastinal area.

Reason for Recall

Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

Recalling Firm

Atrium Medical Corporation — Hudson, NH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

245 cases (1470 units)

Distribution

Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico

Code Information

Lot Number: 242896, 243292

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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