FDA recall Z-2425-2019
Karl Storz Endoscopy · Class II · device
Product
FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Reason for recall
The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.
Distribution
US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA
Key facts
- Status
- Terminated
- Initiation date
- 2019-02-20
- Report date
- 2019-09-04
- Termination date
- 2020-07-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- El Segundo, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2019