Z-1055-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- April 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- All Serial Numbers manufactured/distributed since January 2018
Product Description
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Reason for Recall
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Distribution Pattern
U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.
Code Information
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018