Health product recall

F/O Laryngoscope

Last updated

Summary

Product
F/O Laryngoscope
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalogue number

#1 Mac F/O Laryngoscope

21-056

69061

F/O Laryngoscope Set-Mac, F/O Laryngoscope Set-Mac W/Led

21-056

69696-LED
69696

Issue

Hillrom received reports of mislabeled fiberoptic Mac #1 laryngoscope blades (p/n 69061 lot 21-056). The outer box label stated Mac #1 laryngoscope blades (p/n 69061), but actually contained Mac #2 laryngoscope blades (p/n 69062). The Mac #2 laryngoscope blade (p/n 69062) is a larger size and is correctly marked on the device itself as a Mac #2. If there is a delay during an emergent intubation because the right size is not available, there may be a risk of patient injury.

Recall start date: June 3, 2022

Additional information

Details
Original published date: 2022-06-23
Alert / recall type
Health product recall
Category
Health product - Medical device - Anaesthesiology
Health product - Medical device - Ear, nose and throat
Companies

Welch Allyn, Inc.

4341 State Street Road, Skaneateles Falls, New York, United States, 13153

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-64291