FDA-Device2019-09-11Class II

Flexible Intubation Fiberscope, Model # 11301AB1

Karl Storz Endoscopy
Hazard

The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.

Sold states
US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada
Affected count
14 scopes
Manufactured in
2151 E Grand Ave, N/A, El Segundo, CA, United States
Products
Flexible Intubation Fiberscope, Model # 11301AB1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2447-2019

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