FDA-Device2020-07-15Class II

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

Centurion Medical Products Corporation
Hazard

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

Sold states
US Nationwide distribution including in the state of IL.
Affected count
140 units
Manufactured in
100 Centurion Way, Williamston, MI, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2545-2020

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