Z-0718-2024 Class II Ongoing
FDA device recall Z-0718-2024 was initiated by Olympus Corporation of the Americas on December 4, 2023 and is designated Class II. 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 p… The recall status is ongoing. Affected quantity: 179 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- December 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 179 units
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).
Distribution Pattern
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