Device product
AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Z-1884-2020
Product summary
- Event
- Event 85204
- Status
- Terminated
- Classification
- Class II
- Quantity
- 198 boxes. 3 units per box.
- Official record key
device-enforcement:Z-1884-2020
Official wording
Reason: Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Code information: NTI Catalog Number 9-203-0543.
Distribution pattern: US Nationwide distribution. No governmental.
Derived failure modes
-
Unknown
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.