Recall Z-1066-2022

Karl Storz Endoscopy · initiated April 1, 2022

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)

Codes / lots: 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) UDI Code: 4048551408155 All Serial Numbers manufactured/distributed since January 2018.

Reason for recall

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDA-determined cause: Under Investigation by firm

Action taken

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 achieved. To the extent included in the current applicable instructions for use, the following methods are being removed as reprocessing methods from the instructions for use of the affected endoscopes. +Manual High-Level Disinfection: -Cidex-OPA -Revital-Ox" RESERT (e.g., 2.0% Accelerated Hydrogen Peroxide solution). +Automated Endoscope Reprocessor: -Medivators AER -Reliance EPS -EvoTech ECR Customer Actions: 1. Immediately discontinue use of all high-level disinfection methods for reprocessing affected endoscopes. 2. The affected endoscopes should be sterilized after each use by one of the sterilization methods recommended in the instructions for use specific to each endoscope. 3. If your facility does not have access to a sterilization method recommended in the applicable instructions for use, immediately discontinue use of the affected endoscopes and return products to KARL STORZ. 4. Ensure all relevant personnel in your organization are aware of recall. 5. Updated instructions for use will be available at https://spwebspace.karlstorz.com/sites/HLDCorrection/SitePages/Home.aspx . Once the updated instructions for use are available, discard any prior versions of the instructions for use. Questions: Telephone: 1-888-352-9616 Fax: 1-888-912-7088 E-Mail: karlstorz7041@sedgwick.com

Details

Recall number
Z-1066-2022
Initiated
April 1, 2022
Product code
FAJ – Cystoscope And Accessories, Flexible/Rigid
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
Recalling firm
Karl Storz Endoscopy, El Segundo, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1061-2022 Class IICYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. 04/01/2022Open, Classified
Z-1062-2022 Class II11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. 04/01/2022Open, Classified
Z-1063-2022 Class II11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. 04/01/2022Open, Classified
Z-1064-2022 Class II11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. 04/01/2022Open, Classified
Z-1065-2022 Class II11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. 04/01/2022Open, Classified
Z-1067-2022 Class II11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. 04/01/2022Open, Classified
Z-1068-2022 Class II11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. 04/01/2022Open, Classified
Z-1069-2022 Class II11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. 04/01/2022Open, Classified
Z-1070-2022 Class II11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)…Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. 04/01/2022Open, Classified