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Smiths Medical ASD Inc. recalls Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
Recalled April 28, 2021 · FDA recall Z-1471-2021 · Smiths Medical ASD
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. · FDA Class II
Units
10 devices
Sold at
Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
Description
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.
Product
Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
Manufacturer(s)
Smiths Medical ASD Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →