FDA-Device2021-10-20Class II
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
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
17980 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0092-2022Don't want to check this manually?
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