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 |
Similar To |