FDA-Device2020-05-13Class II
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.
Northgate Technologies, Inc.
Hazard
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Sold states
US Nationwide distribution. No governmental.
Affected count
1238 boxes. 3 units per box.
Manufactured in
1591 Scottsdale Ct, N/A, Elgin, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1885-2020Don't want to check this manually?
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