Device product
Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Z-1311-2013
Product summary
- Event
- Event 55358
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9432 units
- Official record key
device-enforcement:Z-1311-2013
Official wording
Reason: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
Code information: Lot 36835
Distribution pattern: Distributed Nationwide and in Canada.
Derived failure modes
-
Unknown
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.