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Class 2 Device Recall GlideScope Video Laryngoscope |
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| Date Initiated by Firm |
March 31, 2019 |
| Create Date |
March 11, 2020 |
| Recall Status1 |
Terminated 3 on December 14, 2021 |
| Recall Number |
Z-1471-2020 |
| Recall Event ID |
84329 |
| Product Classification |
Laryngoscope, rigid - Product Code CCW
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| Product |
GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03 |
| 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) |
Recalling Firm/
Manufacturer |
Verathon, Inc.
20001 N Creek Pkwy
Bothell WA 98011-8218
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| For Additional Information Contact |
425-892-0230
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Manufacturer 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.
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FDA Determined
Cause 2 |
Error in labeling |
| Action |
On 03/31/2019 the firm communicated a "Field Safety Notice Medical Device Recall" letter to customers via FedEx informing them the firm has identified that the disinfection levels outlined in Table 9 ( Table 9. System Risk Classification ) on page 23 of the Operations & Maintenance Manual (OMM) incorrectly indicates ( X in the table cell) that low level disinfection is the minimum disinfection level required for the reusable Titanium video laryngoscope. The correct reference should be an X in the table cell indicating that high-level disinfection is required. The error in Table 9 contradicts the other references and warnings in the OMM that correctly state The reusable Titanium video laryngoscope is considered a semicritical device intended to contact the airway. It must be thoroughly cleaned and undergo high-level disinfection after each use (pages 6, 21, and 34 of the OMM).
Customers are instructed to:
1) Determine whether their facility currently has a copy of the In-Service USB (0901-0197) or the GlideScope Video Laryngoscopes Operations and Maintenance Manual 0900-4940 Rev.00 (OMM). If so, dispose of
the In-Service USB as well as any printed or saved copies of the OMM.
2) Download and retain the updated GlideScope¿ Video Laryngoscopes Operations and Maintenance Manual 0900-4940 Rev. 01 from the Product Documentation site: https://www.verathon.com/productdocumentation/
3) Review the disinfection of any reusable Titanium video laryngoscopes completed from January 01, 2019 - February 28, 2019 to ensure that high-level disinfection was completed. High level disinfect any units that were or may have been processed using low-level disinfection.
4) Fill out the attached Recall Response Form and return it by email to
CSNotifications@verathon.com. Some facilities may not currently have copies of the In-Service USB (0901-0197) or the OMM subject to this Field Safety Notice (e.g., because they did not retain the In-Service USB or print or save a copy |
| Quantity in Commerce |
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 |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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