FDAFDA · Food and drugs·Recall number Z-0718-2024
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Published January 24, 2024 · Recall initiated: December 4, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- 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.
- Lot
- UDI-DI 00821925043985 Lot KR262848
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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