The Recall Desk

FDA (Devices) recall action 69236

Aerogen Ltd. recalled 4 products on 2014-10-29

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2014-10-29
Critical
0
Units
4,003

Why these products were recalled

Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2014-10-29

    Aerogen Nebulizer Power Adapter Recall Due to Broken Cover

    Aerogen is recalling 323 FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover broke and dislodged from the adapter body.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2014-10-29

    Aerogen Recalls FRIWO Power Adapters for Aeroneb Nebulizer Systems

    Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2014-10-29

    Aerogen Recalls FRIWO Power Adapters for Aeroneb Nebulizer Systems

    Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2014-10-29

    Aerogen Nebulizer Power Adapter Recall Due to Broken Cover

    Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
    Category
    Distribution
    6 states