Reported Mar 16, 2016 · Terminated
GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium…
Verathon, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Verathon, Inc. · 20001 N Creek Pkwy · Bothell, WA · 98011-8218
Is this the product you have?
- GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording
- Affected Product Names and Part Numbers-LoPro
- S30574-0130 (single blade)
- or 0270-0769 (box of 10) -LoPro S40574-0131 (single
- blade) or 0270-0770 (box of 10) -MAC S30574-0132 (single
- blade) or 0270-0771 (box of 10) -MAC S40574-0133 (single blade) or 0270-0772 (box of 10) The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures
- Lot codes and dates
- LOT Number ranges-LoPro
- S3081814 - 093015; -LoPro
- S4081114 - 090315; -MAC
- S3080814 - 101315; -MAC
- S4022514 - 082115
- Amount recalled
- 7733 units (6377 units in the US and 1356 units International)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.
Using this product could cause serious injury, illness or death — stop using it now.
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