Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-1477-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 31, 2021

Date Posted: April 28, 2021

Recall Number: Z-1477-2021

Event ID: 87647

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3825 units

Code Information:

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

Distribution Pattern:

Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated