FDA recall Z-1055-2022

Karl Storz Endoscopy · Class II · device

Product

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

U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.

Key facts

Status
Ongoing
Initiation date
2022-04-01
Report date
2022-05-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Segundo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1055-2022