FDAFDA · Food and drugs·Recall number Z-1905-2020
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter
Published May 13, 2020 · Recall initiated: July 8, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Navigation, Inc.
- Distributor
- US: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MN, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI OUS: France, Germany, Greece, Iceland, Israel, Spain, Sweden, Switzerland, UK
- Lot
- All kits with lot numbers from 0211041602 through 0217695790
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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