FDA-Device2017-06-21Class II
Endoscopic Introducer/Extractor
Cook Inc.
Hazard
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Sold states
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
Affected count
46
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Endoscopic Introducer/Extractor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2538-2017Don't want to check this manually?
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