Z-1471-2020 Class II Terminated
FDA device recall Z-1471-2020 was initiated by Verathon, Inc. on March 31, 2019 and is designated Class II. 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. The recall status is terminated (terminated December 14, 2021). Affected quantity: 239 manuals.
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)