Z-1471-2020 Class II Terminated

Recalled by Verathon, Inc. — Bothell, WA

Recall Details

Product Type
Devices
Report Date
March 18, 2020
Initiation Date
March 31, 2019
Termination Date
December 14, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
239 manuals

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

Code Information

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)