FDA-Device2022-05-18Class II
11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
Karl Storz Endoscopy
Hazard
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Sold states
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,WI, WV, and WY. O.U.S.: Mexico, Lebanon, and South Korea
Affected count
All Serial Numbers manufactured/distributed since January 2018
Manufactured in
2151 E Grand Ave, N/A, El Segundo, CA, United States
Products
11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1064-2022Don't want to check this manually?
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