11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
Reported: May 18, 2022 Initiated: April 1, 2022 #Z-1065-2022
Product Description
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
Reason for Recall
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Details
- Recalling Firm
- Karl Storz Endoscopy
- Units Affected
- 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
- Location
- El Segundo, CA
Frequently Asked Questions
What product was recalled? ▼
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021). Recalled by Karl Storz Endoscopy. Units affected: All Serial Numbers manufactured/distributed since January 2018..
Why was this product recalled? ▼
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1065-2022.
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