FDA-Device2021-10-27Class II
smiths medical portex Loss of Resistance Device, REF 100/398/000
Smiths Medical ASD Inc.
Hazard
The labeling was missing information on sterilization and prohibition of reuse.
Sold states
Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates
Affected count
3420 devices
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
smiths medical portex Loss of Resistance Device, REF 100/398/000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2022Don't want to check this manually?
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