Karl Storz Endoscopy Recall 92796
Description: Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Karl Storz Endoscopy Recall 92796 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2589-2023 |
| Event ID | 92796 |
| Event Description | Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only |
| Product Type | Devices |
| 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. |
| Quantity | 218 units |
| Recall Reason | Flexible intubation endoscopes sterility assurance can not be confirmed. |
| Device Classification | 20230927 |
| Device Code Info | UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461 |
| Center Classification Date | 20230915 |
| Recall Initiation Date | 20230707 |
| Recalling Firm | Karl Storz Endoscopy |
| Initial Notification | Letter |
| Similar To |