Device Recall OptiLite MultiUse Holmium Laser Fibers

OptiLite Multi-Use Holmium Laser Fibers, Catalog Numbers followed by GPN: HLF-M273-CNV, G48611 HLF-M273-SMA, G48522 HLF-M365-CNV, G48613 HLF-M365-SMA, G48618 HLF-M550-CNV, G48615 HLF-M550-SMA, G48619 HLF-M940-CNV, G48617 HLF-M940-SMA, G48621 HLF-M273-CNV-CAN, G51777 HLF-M273-SMA-CAN, G51785 HLF-M365-CNV-CAN, G51778 HLF-M365-SMA-CAN, G51786 HLF-M550-CNV-CAN, G51779 HLF-M550-SMA-CAN, G51787 HLF-M940-CNV-CAN, G51780 HLF-M940-SMA-CAN, G51788

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US Nationwide in the states of: AK AL AZ CA CO FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC NJ NY OH OR PA SC SD TN TX WA WI Foreign: Australia, Bolivia, Brazil, Canada, Chile, Columbia, Cyprus, Czech Republic, Germany, Dominican Republic, Greece, Hong Kong, Ireland, Israel, India, Iran, Jordan, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Latvia, Libya, Mexico, Malaysia, New Zealand, Oman, Panama, Peru, Portugal, Serbia, Turkey, Trinidad and Tobago, Taiwan, and Venezuela. VA/DOD: Yes- see below

OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages || Product Usage: || Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation