Karl Storz Endoscopy recalls 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-
Recalled Product
11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-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: 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.
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