PlainRecalls
FDA Devices Moderate Class II Terminated

BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667

Reported: August 28, 2019 Initiated: June 12, 2019 #Z-2297-2019

Product Description

BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667

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.

Details

Units Affected
1,436,228,004 total
Distribution
Worldwide Distribution, including US Nationwide
Location
Franklin Lakes, NJ

Frequently Asked Questions

What product was recalled?
BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667. Recalled by Becton Dickinson & Company. Units affected: 1,436,228,004 total.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 28, 2019. Severity: Moderate. Recall number: Z-2297-2019.