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U.S. Department of Health and Human Services

Class 2 Device Recall AUTOLITH Touch

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  Class 2 Device Recall AUTOLITH Touch see related information
Date Initiated by Firm April 13, 2022
Create Date June 03, 2022
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = NORTHGATE TECHNOLOGIES INC.
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