11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA recall
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Why was 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA recalled?
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018
- Product
- 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- 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.
- Recall date
- May 18, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)