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 product - Medical device - 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