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
This recall has been terminated (originally issued July 8, 2019).
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- July 8, 2019
- Terminated
- October 16, 2024
- Recall Number
- Z-1905-2020
- Quantity
- 4654 units
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
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
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 / Code Info
All kits with lot numbers from 0211041602 through 0217695790
Root Cause
Nonconforming Material/Component
Action Taken
The firm issued its first customer notification and customer response form on 7/8/2019. On 7/16/2019, a second notification was issued to allow customers to identify recalled product by lot number. On 10/3/2019, the firm issued a third customer notification to include three additional affected lots. The firm requested customers examine inventory for affected lot numbers and quarantine for return to the firm and to complete the attached customer response form.