Karl Storz Endoscopy recalls 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-201
Recalled Product
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Hazard / Issue
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Issued by
FDA
Affected States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, WY
Lot/Code Info: 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) UDI Code: 4048551408155 All Serial Numbers manufactured/distributed since January 2018.
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