FDA-Device2016-06-08Class II
Video Duodenoscope
Pentax Medical Company
Hazard
Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
Sold states
Nationwide
Affected count
423 units
Manufactured in
3 Paragon Dr, N/A, Montvale, NJ, United States
Products
Video Duodenoscope
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1835-2016Don't want to check this manually?
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