11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)

Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Code information: 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018) UDI Code: 4048551226186; 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018) UDI Code: 4048551226193; All Serial Numbers manufactured/distributed since January 2018.

Distribution pattern: 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