Z-1905-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- July 8, 2019
- Termination Date
- October 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4654 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
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
Code Information
All kits with lot numbers from 0211041602 through 0217695790