Home / Recalls / Northgate Technologies, Inc. / Z-1885-2020

Z-1885-2020 Class II Terminated

Recalled by Northgate Technologies, Inc. — Elgin, IL

Recall Details

Product Type
Devices
Report Date
May 13, 2020
Initiation Date
March 10, 2020
Termination Date
February 2, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1238 boxes. 3 units per box.

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.

Distribution Pattern

US Nationwide distribution. No governmental.

Code Information

NTI Catalog Number 72-00198-0.

Other recalls by Northgate Technologies, Inc.

  • Z-1235-2022 Class II — AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe (April 13, 2022)
  • Z-0333-2022 Class II — Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005 (October 25, 2021)
  • Z-1147-2021 Class II — ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product U (January 15, 2021)
  • Z-1148-2021 Class II — Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 71030 (January 15, 2021)
  • Z-1884-2020 Class II — AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: (March 10, 2020)
  • Z-1883-2020 Class II — Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are us (March 10, 2020)
  • Z-0073-2018 Class II — Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with (May 24, 2017)
  • Z-0866-2017 Class II — Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L (November 21, 2016)