Class 2 Device Recall AUTOLITH Touch

• Date Initiated by Firm: April 13, 2022
• Create Date: June 03, 2022
• Recall Status: Terminated on November 08, 2022
• Recall Number: Z-1235-2022
• Recall Event ID: 90095
• 510(K)Number: K130368
• Product Classification: Lithotriptor, electro-hydraulic - Product Code FFK
• Product: AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
• Code Information: NTI Catalog Number 72-00322-0 / BSC Catalog No. M00546620; Lot code: BSC15876; GTIN: 00817183020448.
• 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: Product labeled incorrectly.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm sent out the recall notification to their consignee on 04/13/2022 via email. The firm sent out a letter as well on 04/27/2022 which instructs the consignee to cease distribution, quarantine affected units and return affected product. If the distributor further distributed the product, they are asked to notify their customers.
• Quantity in Commerce: 55 probes
• Distribution: US Nationwide distribution in the state of MA.
• 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