The Recall Desk

FDA (Devices) recall action 72642

Verathon, Inc. recalled 2 products on 2015-12-23

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2015-12-23
Critical
0
Units
—

Why these products were recalled

Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2015-12-23

    Verathon GlideScope AVL Video Laryngoscope Blades Recalled for Separation Risk

    Verathon is recalling GlideScope AVL video laryngoscope blades because silicone adhesive bonding may be inadequate, creating a risk of blade separation during use.

    Product
    GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2015-12-23

    Verathon GlideScope Video Laryngoscope Blades Recalled for Potential Separation

    Verathon is recalling GlideScope Video Laryngoscope blades because silicone adhesive may fail, causing the blade halves to separate during use.

    Product
    GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a
    Category
    Distribution
    2 states