FDA-Device2021-04-28Class II
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Smiths Medical ASD Inc.
Hazard
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
Sold states
Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
Affected count
200 devices
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1470-2021Don't want to check this manually?
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