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Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Recalled January 24, 2024 · FDA recall Z-0718-2024 · 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). · FDA Class II
Units
179 units
Sold at
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.
Description
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).
Product
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →