ICU Medical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1072-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO

Product Classification:

Class II

Date Initiated: November 27, 2018

Date Posted: April 3, 2019

Recall Number: Z-1072-2019

Event ID: 81743

Reason for Recall:

Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.

Status: Terminated

Product Quantity: N/A

Code Information:

Lot/UDI: 3529857/ (01)0 0840619 04495 4 (17) 200901 (30) 01 (10) 3529857

Distribution Pattern:

U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada

Voluntary or Mandated:

Voluntary: Firm initiated