Device product
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Z-1472-2024
Product summary
- Event
- Event 94171
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 190 units
- Official record key
device-enforcement:Z-1472-2024
Official wording
Reason: Inadequate reprocessing validation evidence
Code information: UDI: 04048551050255/ All Lots
Distribution pattern: US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
Derived failure modes
-
Unknown
Inadequate reprocessing validation evidence