Medtronic Navigation, Inc.: Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive su

Hazard

Due to a defect in the outer pouch sterile seal

Details from the source

Reason for recall: Due to a defect in the outer pouch sterile seal Distribution: U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL, KY, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, TX, VA, WA, and WV. Quantity: 95 units Lot/code info: Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769

UPC codes

00763000416430

Source

Official record: FDA (Device enforcement) ↗

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