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Health Canada Medical devices

SOLTIVE™ SuperPulsed Laser Ball Tip Fiber Single Use

Issued January 4, 2024
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
Hazard description
Sterility
Product
Product name
SOLTIVE™ SuperPulsed Laser Ball Tip Fiber Single Use
Reference
ID
RA-74846