11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
Check against the official notice below — it lists the full affected range.
Karl Storz Endoscopy has recalled certain HD-VIEW Flexible HD Cysto-Urethroscope models (11272VH-TL, 11272VHK-TL, 11272VHU-TL, and 11272VHUK-TL) due to failure to achieve the expected six-log reduction in microorganisms following the disinfection process. All serial numbers manufactured or distributed since January 2018 are affected. These devices were distributed throughout the United States (all states and Guam), as well as to Mexico, Lebanon, and South Korea.
The recall record does not specify a remedy or action that affected consumers should take.
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: 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) UDI Code: 4048551449677; 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) UDI Code: 4048551449684; 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.