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.
Z-1883-2020
Product summary
- Event
- Event 85204
- Status
- Terminated
- Classification
- Class II
- Quantity
- 298 boxes. 3 units per box
- Official record key
device-enforcement:Z-1883-2020
Official wording
Reason: As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Code information: NTI Catalog Number 9-900-54.
Distribution pattern: US Nationwide distribution. No governmental.
Derived failure modes
-
Unknown
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.