FDA-Device2021-10-20Class II
smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
Smiths Medical ASD Inc.
Hazard
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Sold states
Austria, France, Germany, Great Britain, and Saudi Arabia
Affected count
140 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0093-2022Don't want to check this manually?
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