Z-1235-2022 Class II Terminated
FDA device recall Z-1235-2022 was initiated by Northgate Technologies, Inc. on April 13, 2022 and is designated Class II. Reason for recall: Product labeled incorrectly. The recall status is terminated (terminated November 8, 2022). Affected quantity: 55 probes.
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2022
- Initiation Date
- April 13, 2022
- Termination Date
- November 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 probes
Product Description
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Reason for Recall
Product labeled incorrectly.
Distribution Pattern
US Nationwide distribution in the state of MA.
Code Information
NTI Catalog Number 72-00322-0 / BSC Catalog No. M00546620; Lot code: BSC15876; GTIN: 00817183020448.