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Smiths Medical ASD Inc. recalls Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD
Recalled April 28, 2021 · FDA recall Z-1476-2021 · 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
1380 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
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and manifolds are used to control the direction of IV fluid flow. 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 →