11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Check against the official notice below — it lists the full affected range.
Karl Storz Endoscopy has recalled certain Flexible Bronchoscope models (11005BC1, 11005BCK1, Z21493US-BA) distributed nationwide across 14 states since January 2018. The devices are being recalled because they fail to achieve the expected reduction in microorganisms during the disinfection process, which means they may not be properly cleaned and sterilized for medical use.
The affected devices were distributed to facilities in Florida, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Oklahoma, South Carolina, Texas, and Washington. The recall notice does not specify what actions affected consumers or healthcare facilities should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
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. Quantity: All Serial Numbers manufactured/distributed since January 2018 Lot/code info: 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.