Z-1883-2020 Class II Terminated
FDA device recall Z-1883-2020 was initiated by Northgate Technologies, Inc. on March 10, 2020 and is designated Class II. Reason for recall: As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. The recall status is terminated (terminated February 2, 2021). Affected quantity: 298 boxes. 3 units per box.
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
- 298 boxes. 3 units per box
Product Description
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 Pattern
US Nationwide distribution. No governmental.
Code Information
NTI Catalog Number 9-900-54.