FDA: Verathon recall of video laryngoscope is Class I

The FDA today labeled a recall notice from Verathon for its GlideScope Titanium single-use video laryngoscope due to issues with potential video feed disruption.

Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The GlideScope laryngoscope is designed to visualize the vocal cords and assist in the insertion of a tracheal tube used during other medical procedures.

The device is being recalled due to a potential disruption in the video feed which may lead to delayed tracheal tube insertion, intubation failure and other serious adverse health consequences, according to the recall notice.

A total of 6,377 units are being affected by the recall, manufactured between November, 2014 and December, 2015 and distributed between November 14, 2014 and December 29, 2015.

Model codes LoPro S3, S4, Mac S3 and S4 and lot numbers LoPro S3: 081814 – 093015, LoPro S4: 081114 – 090315, MAC S3: 080814 – 101315, and MAC S4: 022514 – 082115 were named in the recall.

The firm said it sent out a letter in January to customers with the devices, instructing them to return or destroy any affected products.

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