Electrohydraulic lithotripter probe recalled over labeling errors

Recall date

May 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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.…

Recall number

Z-0073-2018

FDA classification

Class II

Brand / firm

Northgate Technologies, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.