Home / Recalls / Medical Devices
Northgate Technologies, Inc. recalls Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter.
Recalled November 15, 2017 · FDA recall Z-0073-2018 · Northgate Technologies
Hazard
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 Class II
Units
186
Sold at
US Distribution to the following states : MA, NE and TN and Internationally to Canada.
Description
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.
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.
Manufacturer(s)
Northgate Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →