Karl Storz Endoscopy Recall 88694
Description: FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Karl Storz Endoscopy Recall 88694 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0184-2022 |
| Event ID | 88694 |
| Event Description | FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units) |
| Product Type | Devices |
| Distribution | US: SC, NH, UT, LA, FL, TX, MA, MO, VA, IA, CA, IL, NC, VT, AL, GA, PA, TN, WI, NY, CO, AZ, NV, ME, MS, DC, IN, KY, MD, OH, MI, WA, KS, OR, AR, MN, NJ, NM, WV, CT. OUS: Canada |
| Quantity | 532 |
| Recall Reason | During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection. |
| Device Classification | 20211110 |
| Device Code Info | All LOTs with remaining shelf life |
| Center Classification Date | 20211029 |
| Recall Initiation Date | 20210910 |
| Recalling Firm | Karl Storz Endoscopy |
| Initial Notification | Letter |
| Similar To |