Recall Z-1063-2022 ยท FBO Cystourethroscope
Karl Storz Endoscopy
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)
| Date | Apr 1, 2022 |
| Status | Open, Classified |
| Reason | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| Root cause | Under Investigation by firm |
| Action | On 04/01 and 6/2022, the firm emailed an "Urgent Medical Device Recall" letter to customers and followed up with a hardcopy letter on 04/07-08/2022 via their Third Party contractor informing customers of a labeling update to correct the instructions for use for certain flexible urological endoscopes and advise that high-level disinfection should not be used as a method of reprocessing. Supplemental validation testing of the efficacy of the manual high-level disinfection process using CIDEX OPA was performed. Testing showed that required efficacy level of disinfection using CIDEX OPA was not |
| Quantity | All Serial Numbers manufactured/distributed since January 2018 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System Karl Storz Endoscopy America, Inc., Sep 3, 2021 |