ICU Medical, Inc. recalls ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transduc…

Recall date

November 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1072-2019

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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