CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report

BD Vacutainer Lithium HeparinN recalled by Becton Dickinson &

Becton Dickinson is recalling BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, distributed nationwide in the US. The recall was initiated on 12 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)30382903666646

Quantity recalled1,436,228,004 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2296-2019
FDA event ID: 82963
Recalling firm: Becton Dickinson, Franklin Lakes, NJ
Classification: Class II
Status: Terminated
Recall initiated: 12 Jun 2019
FDA classified: 21 Aug 2019
Reported: 28 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

12 Jun 2019	Recall initiated by company
21 Aug 2019	Classified by FDA	+70 days
28 Aug 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution, including US Nationwide

Nationwide

Questions about this recall

Why was it 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 lots are affected?

UDI: (01)30382903666646

Where was it sold?

Worldwide Distribution, including US Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

14 other products · FDA event 82963

This product is part of a recall event; the main page for the event is BD Vacutainer Lithium HeparinN recalled by Becton Dickinson &.

Reported	Class	Recall	Company	Reason	Where
28 Aug 2019	CLASS II	BD Vacutainer Lithium HeparinN recalled by Becton Dickinson &	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer PST Gel and Lithium HeparinN recalled	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer PST Gel and Lithium HeparinN recalled	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer LH (Lithium Heparin) 34 I.U recalled by Becton Dickinson &	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer Lithium HeparinN recalled by Becton Dickinson &	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer PST Gel and Lithium HeparinN recalled	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer PST Gel and Lithium HeparinN recalled	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer LH (Lithium Heparin) 68 I.U recalled by Becton Dickinson &	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes recalled	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer LH (Lithium Heparin) 102 I.U recalled	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer PST Blood Collection Tubes recalled by Becton Dickinson &	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer Lithium HeparinN recalled by Becton Dickinson &	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer PST Gel and Lithium HeparinN recalled	Becton Dickinson	Other	Nationwide
28 Aug 2019	CLASS II	BD Vacutainer PST Gel and Lithium HeparinN recalled	Becton Dickinson	Other	Nationwide

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