Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-1479-2021)

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:

HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.

Product Classification:

Class II

Date Initiated: March 31, 2021

Date Posted: April 28, 2021

Recall Number: Z-1479-2021

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: 8150 units

Code Information:

a. Model Number MX496HP, Lot Numbers: 3952480, 3974771 b. Model Number MX497HP, Lot Numbers: 3949391, 3971003

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