FDA-Device2019-09-04Class II
FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Karl Storz Endoscopy
Hazard
The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.
Sold states
US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA
Affected count
22 scopes
Manufactured in
2151 E Grand Ave, N/A, El Segundo, CA, United States
Products
FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2019Don't want to check this manually?
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