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 - Sterility
What to do

Review notice, cease use/quarantine and return affected product, complete/return online response form. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

SOLTIVE™ SuperPulsed Laser Ball Tip Fiber Single Use

KR262848

TFL-FBX200BS

Issue

Olympus (Gyrus ACMI, Inc.) is initiating a recall and advising customers of the potential for a breached sterile pouch seal on the 200 Micron TFL ball tip single-use soltive laser fiber. Olympus has received one (1) complaint regarding a breach of the TFL-FBX200BS laser fiber pouch seal. Initial investigation shows this to be an isolated event.

Recall start date: December 12, 2023

Additional information

Details
Original published date:
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 II
Identification number
RA-74846

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