FDA-Device2024-01-24Class II
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Olympus Corporation of the Americas
Hazard
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
Sold states
Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe.
Affected count
179 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0718-2024Don't want to check this manually?
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