Northgate Technologies Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic recall — FDA Z-0333-2022
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
Overview of recall records associated with Northgate Technologies, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 5.
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
This page summarizes recall records in which the official source identifies Northgate Technologies, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.