11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
Check against the official notice below — it lists the full affected range.
Karl Storz is recalling certain flexible video urethro cystoscopes (medical instruments used to examine the urethra and bladder) distributed in the United States, Mexico, Lebanon, and South Korea since January 2018. The devices are not achieving the expected level of microorganism reduction during the disinfection process, which means they may not be adequately disinfected before use on patients.
The affected models are the 11272VN, 11272VNK, 11272VNU, and 11272VNUK Flexible Video Urethro Cystoscopes. The recall covers all serial numbers of these models manufactured or distributed since January 2018. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Reason for recall: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Distribution: 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 Quantity: All Serial Numbers manufactured/distributed since January 2018 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.