FDA recall Z-1883-2020

Northgate Technologies, Inc. · Class II · device

Product

Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

Reason for recall

As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Distribution

US Nationwide distribution. No governmental.

Key facts

Status
Terminated
Initiation date
2020-03-10
Report date
2020-05-13
Termination date
2021-02-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elgin, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1883-2020