medical Class II Updated 2024-01-24

Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

Recalled Product

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS


Hazard / Issue

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).

Issued by

FDA

Affected 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
Lot/Code Info: UDI-DI 00821925043985 Lot KR262848
View official government recall

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