Device product
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Z-0837-2025
Product summary
- Event
- Event 95954
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 285 units
- Official record key
device-enforcement:Z-0837-2025
Official wording
Reason: Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Code information: Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416
Distribution pattern: US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA OUS: None
Derived failure modes
-
Unknown
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.