Flexible Bronchoscope Recalled Due to Inadequate Disinfection Process
Karl Storz is recalling flexible bronchoscopes due to potential failure of the disinfection process. The devices may not eliminate microorganisms adequately, posing an infection risk to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving inadequate microbial disinfection of a reusable invasive medical device. No illnesses or injuries reported in the source. Classified as 'High' per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Karl Storz Endoscopy is recalling certain flexible bronchoscopes, models 11005BC1 and 11005BCK1 (Z21493US-BA, manufactured June 2019). All serial numbers manufactured or distributed since January 2018 are subject to this recall.
The recalled bronchoscopes may fail to achieve the expected six-log reduction in microorganisms during the disinfection process. This disinfection failure could result in inadequate microbial elimination and potential infection transmission to patients undergoing bronchoscopy procedures.
These devices were distributed nationwide in the following states: Florida, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Oklahoma, South Carolina, Texas, and Washington.
For recall information and guidance, users should contact Karl Storz Endoscopy.
The recalled product
- Product
- 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 2,018
Distribution
Part of a larger recall action
This product is one of 2 recalled by Karl Storz Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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