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

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).

Details from the source

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: 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. Quantity: 179 units Lot/code info: UDI-DI 00821925043985 Lot KR262848

UPC codes

00821925043985

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.