Centurion Medical Products Corporation recalls Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 36…

Recall date

June 1, 2019

Source

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

Recall number

Z-2545-2020

FDA classification

Class II

Brand / firm

Centurion Medical Products Corporation

Sold / distributed

US Nationwide distribution including in the state of IL.

Why it was recalled

False elevation of carboxyhemoglobin (COHb) results in blood samples collected using BD Vacutainer¿ Plastic Lithium Heparin tubes with the IL GEM 4000 instrument.

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

What was recalled

Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860