Z-2298-2019 Class II Terminated

Recalled by Becton Dickinson & Company — Franklin Lakes, NJ

Recall Details

Product Type
Devices
Report Date
August 28, 2019
Initiation Date
June 12, 2019
Termination Date
June 29, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,436,228,004 total

Product Description

BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880

Reason for Recall

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

Distribution Pattern

Worldwide Distribution, including US Nationwide

Code Information

UDI: (01)30382903678809