Recall Z-1885-2020— Northgate Technologies, Inc.

Name: FDA recall Z-1885-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-10

Class II · Terminated

Class II FDA medical device recall by Northgate Technologies, Inc., initiated 2020-03-10, terminated 2021-02-02. It names one FDA 510(k) clearance: K914516. 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.. Reason: Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing..

Recalling firm: Northgate Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-03-10
Terminated: 2021-02-02
Firm location: Elgin, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K914516 — 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATIONNorthgate Technologies, Inc.·cleared 1992-01-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.