Verathon, Inc. recalls GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
- Recall date
- March 31, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1471-2020
- FDA classification
- Class II
- Brand / firm
- Verathon, Inc.
- Sold / distributed
- 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
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
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