Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intend...
FDA Recall #Z-1208-2017 — Class II — December 23, 2016
Product Description
Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N 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
681 cases (4086 units)
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
Code Information
Lot Number: 242919, 242920
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated