Recall Z-2589-2023 · EOQ Bronchoscope (Flexible Or Rigid)
Karl Storz Endoscopy
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
| Date | Sep 15, 2023 (initiated Jul 7, 2023) |
| Status | Open, Classified |
| Reason | Flexible intubation endoscopes sterility assurance can not be confirmed. |
| Root cause | Process change control |
| Action | On August, 4, 2023, Karl Storz Endoscopy issued an Urgent Medical Device Recall Notification via: UPS. Karl Storz asked consignees to take the following actions: 1. Immediately quarantine and discontinue use of Material numbers listed above. 2. Pass on this Urgent Medical Device Recall notice to all users of the products listed above and all other persons who need to be aware within your organization. 3. If you have distributed the products listed, please promptly forward this letter to those recipients, and indicate contact details of the recipient on the Customer Reply From. 4. Return the |
| Quantity | 218 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212656 | Flexible Intubation Video Endoscope Sterile (FIVE-S) Karl Storz Endoscopy America, Dec 29, 2021 |