Class 2 Device Recall AUTOLITH 9 FR Probe

• Date Initiated by Firm: March 10, 2020
• Date Posted: March 24, 2020
• Recall Status: Terminated on February 02, 2021
• Recall Number: Z-1883-2020
• Recall Event ID: 85204
• 510(K)Number: K130368
• Product Classification: Lithotriptor, electro-hydraulic - Product Code FFK
• Product: Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
• Code Information: NTI Catalog Number 9-900-54.
• Recalling Firm/ Manufacturer: Northgate Technologies, Inc.; 1591 Scottsdale Ct; Elgin IL 60123-9361
• For Additional Information Contact: Laura MacMillian; 800-348-0424
• Manufacturer Reason for Recall: As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Northgate Technologies, Inc. notified customers on 03/11/2020 via "Urgent: medical Device Recall Notification" email. The recall notice identified the affected and requested the customers to cease distribution and destroy affected product. The customers were asked to complete the "Recall Acknowledgment Form".
• Quantity in Commerce: 298 boxes. 3 units per box
• Distribution: US Nationwide distribution. No governmental.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = FFK