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U.S. Department of Health and Human Services

Class 2 Device Recall 9195371DS Lithrotripsy Probe LotLDS12516

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  Class 2 Device Recall 9195371DS Lithrotripsy Probe LotLDS12516 see related information
Date Initiated by Firm May 24, 2017
Create Date November 08, 2017
Recall Status1 Terminated 3 on June 09, 2020
Recall Number Z-0073-2018
Recall Event ID 77367
510(K)Number K914514  
Product Classification Lithotriptor, electro-hydraulic - Product Code FFK
Product Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
Code Information Model No. 9-195-371DS, Lot/Serial Number LDS12516
Recalling Firm/
Manufacturer		 Northgate Technologies, Inc.
1591 Scottsdale Ct
Elgin IL 60123-9361
For Additional Information Contact
800-348-0424
Manufacturer Reason
for Recall		 The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.
FDA Determined
Cause 2		 Labeling mix-ups
Action Northgate Technologies sent an Urgent Medical Device Recall Notification dated May 24, 2017. Instructions included to examine records and locate affected devices, cease distribution or use and quarantine any affected products, return any affected product to Northgate, and contact customers if the affected product has been further distributed. For further questions, please call (800) 348-0424.
Quantity in Commerce 186
Distribution US Distribution to the following states : MA, NE and TN and Internationally to Canada.
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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