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Northgate Technologies, Inc. recalls AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of
Recalled May 13, 2020 · FDA recall Z-1884-2020 · Northgate Technologies
Hazard
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. · FDA Class II
Units
198 boxes. 3 units per box.
Sold at
US Nationwide distribution. No governmental.
Description
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Product
AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - 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 →