Home / Recalls / Medical Devices
Northgate Technologies, Inc. recalls ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - P
Recalled May 13, 2020 · FDA recall Z-1885-2020 · Northgate Technologies
Hazard
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. · FDA Class II
Units
1238 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
ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - 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 →