Karl Storz Endoscopy Recall 89880
Description: 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)
Karl Storz Endoscopy Recall 89880 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1063-2022 |
| Event ID | 89880 |
| Event Description | 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) |
| Product Type | Devices |
| 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 |
| Recall Reason | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| Device Classification | 20220518 |
| Device 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. |
| Center Classification Date | 20220512 |
| Recall Initiation Date | 20220401 |
| Recalling Firm | Karl Storz Endoscopy |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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