CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
Check against the official notice below — it lists the full affected range.
Karl Storz Endoscopy is recalling cystoscope models 11272C1, 11272C2, 11272CK2, 11272CU1, and 11272CUK1 due to a failure to achieve the expected six-log reduction in microorganisms following the disinfection process. These are flexible cystoscopes used in urological procedures. The devices were manufactured and distributed since January 2018 and have been distributed throughout the United States (including all 50 states, Washington D.C., and Guam), as well as in Mexico, Lebanon, and South Korea.
The recall applies to all serial numbers of the affected models manufactured or distributed since January 2018. The source document does not specify a remedy or recommended action for consumers who have these devices.
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: 11272C1 n/a Flexible Cysto-Urethroscope Fiberscope Z18449US-BD (08-2018) UDI Code: 4048551226100; 11272C2 11272CK2 Flexible Cystoscope Z18449US-BD (08-2018) UDI Code: 4048551226100; 11272CU1 11272CUK1 Flexible Cystoscope Z18449US-BD (08-2018) UDI Code: 4048551226162; 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.