Karl Storz Endoscopy Recall 89881
Description: 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Karl Storz Endoscopy Recall 89881 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1055-2022 |
| Event ID | 89881 |
| Event Description | 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA. |
| Quantity | All Serial Numbers manufactured/distributed since January 2018 |
| Recall Reason | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| Device Classification | 20220518 |
| Device Code Info | 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018 |
| Center Classification Date | 20220510 |
| Recall Initiation Date | 20220401 |
| Recalling Firm | Karl Storz Endoscopy |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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