Z-2545-2020 Class II Terminated

Recalled by Centurion Medical Products Corporation — Williamston, MI

Recall Details

Product Type
Devices
Report Date
July 15, 2020
Initiation Date
June 1, 2019
Termination Date
June 21, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
140 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide distribution including in the state of IL.

Code Information

Lot Number: 2019050790 exp. Date: 10/31/2019