medical Class II Updated 2021-04-28

Smiths Medical ASD Inc. recalls Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF

Recalled Product

Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: a. Model Number MX1431MR, Lot Numbers: 3995544 b. Model Number MX1431MRL, Lot Numbers: 3995545, 4011838, 4027758, 4033501, 4044959 c. Model Number MX4331R, Lot Numbers: 3971467, 3987918
View official government recall

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