Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-1480-2021)

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:

Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.

Product Classification:

Class II

Date Initiated: March 31, 2021

Date Posted: April 28, 2021

Recall Number: Z-1480-2021

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: 11340 units

Code Information:

a. REF 601280, Lot Numbers: 3872300, 3946984 b. REF 601281, Lot Numbers: 3872301, 4024481

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