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Smiths Medical ASD Inc. recalls Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transduce
Recalled April 28, 2021 · FDA recall Z-1481-2021 · 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
500 units
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
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Manufacturer(s)
Smiths Medical ASD Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →