FDA recall Z-1471-2020

Verathon, Inc. · Class II · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2019-03-31
Report date
2020-03-18
Termination date
2021-12-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1471-2020