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

Class II FDA enforcement event 82963. Recall start date: 12 Jun 2019. Status in the FDA record: Terminated. Termination date: 29 Jun 2020.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Becton Dickinson & Company started this device recall on 12 Jun 2019. The firm address in the FDA record is in Franklin Lakes, NJ. FDA put the recall in Class II. FDA event 82963 has 15 product records. The first FDA enforcement report date is 28 Aug 2019. The record gives the status Terminated, with the termination date 29 Jun 2020.

FDA enforcement report The 15 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution, including US Nationwide

Recalling firm

Becton Dickinson & Company, Franklin Lakes, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

15 product records in the event.

FDA event 82963: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2296-2019	BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2297-2019	BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2298-2019	BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2299-2019	BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2300-2019	BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2301-2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2302-2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2303-2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2304-2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2305-2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2306-2019	BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2307-2019	BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2308-2019	BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2309-2019	BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884	1,436,228,004 total	Class II	Terminated	28 Aug 2019
Z-2310-2019	BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886	1,436,228,004 total	Class II	Terminated	28 Aug 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 15Median of the firm: 1
Events of the firm on the register: 84

Other events of the firm

Other FDA enforcement events of Becton Dickinson & Company
Initiated	Product (first record)	Type	Class	Records
27 Apr 2026	BD Spinal Tray with BD Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8	Device	Class I	10
27 Jan 2026	10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.	Device	Class II	1
14 Oct 2025	BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;	Device	Class II	1
16 Nov 2023	PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number	Device	Class II	1
11 Oct 2023	BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tu	Device	Class II	3
1 Feb 2023	BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment	Device	Class II	8
15 Sep 2022	BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transportin	Device	Class II	1
18 Jul 2022	BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically	Device	Class II	1
9 May 2022	BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)	Device	Class II	11
6 Jan 2022	BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a ca	Device	Class III	1

Becton Dickinson & Company: all 84 events

Official channels

FDA enforcement report Z-2296-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 82963. https://recallregister.com/fda/ii/82963/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution, including US Nationwide
What quantity of product is in FDA event 82963?: The event has 15 product records. The first record gives this quantity: 1,436,228,004 total
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.