Verathon Recalls GlideScope Video Laryngoscope Operations and Maintenance Manuals
Verathon, Inc. is recalling 239 GlideScope Video Laryngoscope Operations & Maintenance Manuals due to a typographical error regarding disinfection instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a minor labeling error (typographical error) regarding disinfection instructions, which fits the criteria for a moderate severity recall involving minor labeling errors.
Plain-English summary
Verathon, Inc. is recalling 239 copies of the GlideScope Video Laryngoscope Operations & Maintenance Manual (Catalog # 0900-4940, Rev. 03). The recall is due to a typographical error in the manual that incorrectly identifies the use of low-level disinfection for the reusable video laryngoscope, specifically for the Titanium Blades.
The affected manuals were distributed to facilities in 32 U.S. states and Canada. The specific product serial numbers for the affected GlideScope Video Laryngoscope units are listed in Appendix A of the associated documents.
Healthcare facilities should stop using the affected manuals and contact Verathon, Inc. for a replacement or further instructions.
The recalled product
- Product
- GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
- Manufacturer
- Verathon, Inc.
- Category
- Medical Device — Manuals
- Hazard
- Affected units
- 239
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2019 February 28
Distribution
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