FDA recall Z-0073-2018

Northgate Technologies, Inc. · Class II · device

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.

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.

Distribution

US Distribution to the following states : MA, NE and TN and Internationally to Canada.

Key facts

Status
Terminated
Initiation date
2017-05-24
Report date
2017-11-15
Termination date
2020-06-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elgin, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0073-2018