| Class 2 Device Recall Visualase Cooled Laser Applicator System |  |
Date Initiated by Firm | July 08, 2019 |
Create Date | May 06, 2020 |
Recall Status1 |
Terminated 3 on October 16, 2024 |
Recall Number | Z-1905-2020 |
Recall Event ID |
85354 |
510(K)Number | K071328 |
Product Classification |
Powered laser surgical instrument - Product Code GEX
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Product | 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 |
Code Information |
All kits with lot numbers from 0211041602 through 0217695790 |
Recalling Firm/ Manufacturer |
Medtronic Navigation, Inc. 826 Coal Creek Cir Louisville CO 80027-9710
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For Additional Information Contact | 720-890-3200 |
Manufacturer 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. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | 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. |
Quantity in Commerce | 4654 units |
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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GEX
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