Device product
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Z-0718-2024
Product summary
- Event
- Event 93629
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 179 units
- Official record key
device-enforcement:Z-0718-2024
Official wording
Reason: 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).
Code information: UDI-DI 00821925043985 Lot KR262848
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.
Derived failure modes
-
Unknown
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).