CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
BD Vacutainer LH (Lithium Heparin) 68 I.U recalled by Becton Dickinson &
Becton Dickinson & is recalling BD Vacutainer LH (Lithium Heparin) 68 I.U, 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
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-2309-2019
- 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 LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
Where it was distributed
Worldwide Distribution, including US Nationwide
Questions about this recall
Is BD Vacutainer LH (Lithium Heparin) 68 I.U recalled?
Yes. Becton Dickinson & recalled BD Vacutainer LH (Lithium Heparin) 68 I.U on 12 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-2309-2019.
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)30382903659037
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Becton Dickinson &
All 361| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson & | Becton Dickinson & | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson & | Becton Dickinson & | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Quincke Needle recalled by Becton Dickinson & | Becton Dickinson & | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson & | Becton Dickinson & | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle, BD¿Quincke Needle recalled | Becton Dickinson & | Processing Deviation | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | Bd Switzerland Sarl | Other | IL |