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U.S. Department of Health and Human Services

Class 2 Device Recall AUTOLITH

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  Class 2 Device Recall AUTOLITH see related information
Date Initiated by Firm March 10, 2020
Date Posted March 24, 2020
Recall Status1 Terminated 3 on February 02, 2021
Recall Number Z-1884-2020
Recall Event ID 85204
510(K)Number K130368  
Product Classification Lithotriptor, electro-hydraulic - Product Code FFK
Product AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Code Information NTI Catalog Number 9-203-0543.
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		 Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
FDA Determined
Cause 2		 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 198 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 and Original Applicant = NORTHGATE TECHNOLOGIES INC.
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