The Recall Desk

FDA (Devices) recall action 75707

Atrium Medical Corporation recalled 7 products on 2017-02-22

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2017-02-22
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–7 of 7

  • HighFDA (Devices)··2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction OASIS Drain

    Atrium Medical Corporation is recalling 18 units of Maquet Express Dry Seal Suction OASIS Drain because the manual vent valve may fail to re-seal.

    Product
    Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 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 re
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction Chest Drains

    Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction chest drains because the manual vent valve may fail to re-seal after being depressed.

    Product
    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 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 reinfu
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-02-22

    Atrium Medical Recalls Maquet Ocean Water Seal Chest Drains

    Atrium Medical Corporation is recalling Maquet Ocean Water Seal Chest Drains because the manual vent valve may fail to re-seal after use.

    Product
    Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction OCEAN DRAIN Chest Drains

    Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction OCEAN DRAIN chest drains because the manual vent valve may fail to re-seal after use.

    Product
    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 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 reinfusio
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-02-22

    Atrium Medical Recalls Maquet Oasis Chest Drains Due to Valve Defect

    Atrium Medical is recalling Maquet Oasis chest drains because the manual vent valve may fail to re-seal after use.

    Product
    Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 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 colle
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-02-22

    Atrium Medical Recalls Maquet Ocean Water Seal Chest Drains

    Atrium Medical is recalling Maquet Ocean Water Seal Chest Drains because the manual vent valve may fail to re-seal after being depressed.

    Product
    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 r
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction Chest Drains

    Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction Chest Drains because the manual vent valve may fail to re-seal after being depressed.

    Product
    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 collecti
    Category
    Distribution
    0 states