Health product recall

Soltive Superpulsed Laser Ball Tip Fiber Single Use

Brand(s)
Last updated

Summary

Product
Soltive Superpulsed Laser Ball Tip Fiber Single Use
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Soltive Superpulsed Laser Ball Tip Fiber Single Use

KR149856

TFL-FBX150BS

Issue

Olympus has received a limited number of complaints that the laser fiber size on the label did not match the product's size. These complaints were identified by users during preparation for use. Olympus investigations confirmed that the model and size of laser fibers may be mismatched between the product's carton (box of 5), immediate pouch packaging and/or the device. One lot number was sold in Canada.

Recall start date: May 26, 2022

Additional information

Details
Original published date: 2022-06-10
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Gyrus Acmi, Inc

9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445

Published by
Health Canada
Audience
Healthcare
Recall class
Type III
Identification number
RA-64242