Recall Z-0073-2018— Northgate Technologies, Inc.

Name: FDA recall Z-0073-2018
Creator: U.S. Food and Drug Administration
Published: 2017-05-24

Class II · Terminated

Class II FDA medical device recall by Northgate Technologies, Inc., initiated 2017-05-24, terminated 2020-06-09. It names one FDA 510(k) clearance: K914514. 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: 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..

Recalling firm: Northgate Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-24
Terminated: 2020-06-09
Firm location: Elgin, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K914514 — 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATIONNorthgate Technologies, Inc.·cleared 1992-01-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.