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SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

FDA Recall #Z-0718-2024 — Class II — December 4, 2023

Recall #Z-0718-2024 Date: December 4, 2023 Classification: Class II Status: Ongoing

Product Description

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

Reason for Recall

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).

Recalling Firm

Olympus Corporation of the Americas — Center Valley, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

179 units

Distribution

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.

Code Information

UDI-DI 00821925043985 Lot KR262848

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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