FDAClass IIMarch 18, 2020

GlideScope Video Laryngoscope recall

GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03

Why was GlideScope Video Laryngoscope recalled?

A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level disinfection for the reusable video laryngoscope, specifically for the Titanium Blades.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GlideScope Video Laryngoscope Operation and Maintenance Manual Catalog #: 0900-4940 Product can be further identified as In-Service USB 0901-0197 Affected Revision Rev. 00 distributed January 1, 2019 February 28, 2019 GlideScope Video Laryngoscope Product Serial Numbers are included in Appendix A: Domestic and Foreign Consignee List (in Associated Documents)

Product
GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
Recalling firm
Verathon, Inc.
Quantity
239 manuals
Distribution
US: RI, IL, FL, SD, NY, MD, CA, OH, LA, AZ, GA, WA, OK, NC, AL, PA, TN, NJ, NV, MI, OR, TX, NM, VA, UT, NE, WI, CO, AR, MN, CT, ND, and KS. OUS: Canada
Recall date
March 18, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls