Recall Z-3218-2024 ยท FGA Kit, Nephroscope
Karl Storz Endoscopy
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
| Date | Sep 24, 2024 (initiated Jul 23, 2024) |
| Status | Open, Classified |
| Reason | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| Root cause | Process design |
| Action | On August 2, 2024, Karl Storz -Endoskope issued a "Urgent: Medical Device Correction" Notification to affected consignees via UPS Ground. Karl Storz asked consignees to take the following actions: 1. Immediately discard any previous revisions of the IFU. 2. Access the updated e-IFU at Karl Storz website 3. Pass on this Urgent Medical Device Correction to all users of the products listed and all other persons who need to be aware within your organization. 4. If you have further distributed the products listed, please identify and promptly notify those recipients of this notice and updated e |
| Quantity | 425 units |
| Distribution | US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, WY, Puerto Rico, Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232370 | Percutaneous Nephroscope System Karl Storz SE & CO. KG, May 1, 2024 |