11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
- Company
- Karl Storz Endoscopy
- Recall Initiated
- April 1, 2022
- Recall Number
- Z-1062-2022
- Quantity
- All Serial Numbers manufactured/distributed since January 2018
- Firm Location
- El Segundo, CA
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
Lot / Code Info
11272V N/A Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551313350; 11272VA 11272VAK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551402481; 11272VU 11272VUK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551313367; 11272VUA 11272VUAK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551402559; All Serial Numbers manufactured/distributed since January 2018.
Root 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