Z-2296-2019Class II

BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664

Name: Z-2296-2019 BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
Creator: Becton Dickinson & Company
Published: 2019-06-12
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-06-12 / Terminated / root cause: design

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664 on 2019-06-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2296-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-12
Posted: 2019-08-21
Terminated: 2020-06-29
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers.
Quantity in commerce: 1,436,228,004 total
Distribution: Worldwide Distribution, including US Nationwide
Product codes and lots: UDI: (01)30382903666646

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2296-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2296-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2297-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2298-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2299-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2300-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2301-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2302-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2303-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2304-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2305-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2306-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2307-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2308-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2309-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2310-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21

Product code JKA

K901449Class IIVacutainer Plus with Hemogard ClosureBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1990-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)