FDA recall Z-1235-2022
Northgate Technologies, Inc. · Class II · device
Product
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Reason for recall
Product labeled incorrectly.
Distribution
US Nationwide distribution in the state of MA.
Key facts
- Status
- Terminated
- Initiation date
- 2022-04-13
- Report date
- 2022-06-15
- Termination date
- 2022-11-08
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Elgin, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1235-2022