Device product
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Z-1235-2022
Product summary
- Event
- Event 90095
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 probes
- Official record key
device-enforcement:Z-1235-2022
Official wording
Reason: Product labeled incorrectly.
Code information: NTI Catalog Number 72-00322-0 / BSC Catalog No. M00546620; Lot code: BSC15876; GTIN: 00817183020448.
Distribution pattern: US Nationwide distribution in the state of MA.
Derived failure modes
-
Unknown
Product labeled incorrectly.