FDA-Device2021-04-28Class II
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
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
500 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1481-2021Don't want to check this manually?
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