11272v Cmos Video-cysto-urethroscope REV 11272va recall
11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US…
Why was 11272v Cmos Video-cysto-urethroscope REV 11272va recalled?
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US…
- Recalling firm
- Karl Storz Endoscopy
- 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
- Recall date
- May 18, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)