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.
FDA Recall Z-0073-2018 · Posted None
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Recalling FirmNorthgate Technologies, Inc.
Recall StatusTerminated
Product CodeFFK
Date Initiated2017-05-24
Date Terminated2020-06-09
Product Quantity186
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
US Distribution to the following states : MA, NE and TN and Internationally to Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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