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Recall Observatory FDA recall evidence

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.

Z-0073-2018

May 24, 2017

Class II

Product summary

Firm
Northgate Technologies, Inc.
Event
Event 77367
Status
Terminated
Classification
Class II
Quantity
186
Official record key
device-enforcement:Z-0073-2018

Official wording

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.

Code information: Model No. 9-195-371DS, Lot/Serial Number LDS12516

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled