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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