Karl Storz Endoscopy Recall 93328
Description: Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
Karl Storz Endoscopy Recall 93328 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0572-2024 |
| Event ID | 93328 |
| Event Description | Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A |
| Product Type | Devices |
| Distribution | US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, Germany |
| Quantity | 990 |
| Recall Reason | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. |
| Device Classification | 20231227 |
| Device Code Info | REF/UDI-DI: 27030N/4048551257180, 27182A/4048551081457 All lot numbers. |
| Center Classification Date | 20231218 |
| Recall Initiation Date | 20231024 |
| Recalling Firm | Karl Storz Endoscopy |
| Initial Notification | Letter |
| Similar To |