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Northgate Technologies, Inc. recalls Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/rena
Recalled May 13, 2020 · FDA recall Z-1883-2020 · Northgate Technologies
Hazard
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. · FDA Class II
Units
298 boxes. 3 units per box
Sold at
US Nationwide distribution. No governmental.
Description
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Product
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Manufacturer(s)
Northgate Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →