FDAFDA · Food and drugs·Recall number Z-1055-2022
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Published May 18, 2022 · Recall initiated: April 1, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Karl Storz Endoscopy
- Distributor
- U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.
- Lot
- 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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