FDA-Device2022-05-18Class II
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Karl Storz Endoscopy
Hazard
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Sold states
U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.
Affected count
All Serial Numbers manufactured/distributed since January 2018
Manufactured in
2151 E Grand Ave, N/A, El Segundo, CA, United States
Products
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1055-2022Don't want to check this manually?
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