11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Reported: May 18, 2022 Initiated: April 1, 2022 #Z-1055-2022
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.
Details
- Recalling Firm
- Karl Storz Endoscopy
- Units Affected
- All Serial Numbers manufactured/distributed since January 2018
- Distribution
- U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.
- Location
- El Segundo, CA
Frequently Asked Questions
What product was recalled? ▼
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019). Recalled by Karl Storz Endoscopy. Units affected: All Serial Numbers manufactured/distributed since January 2018.
Why was this product recalled? ▼
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1055-2022.
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