BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units… recallZ-2307-2019 · Becton Dickinson & Company · initiated Jun 12, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers.
Recall details
- Recall number
- Z-2307-2019
- Status
- Terminated
- Initiated by the company
- Jun 12, 2019
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 1,436,228,004 total
- Product code
- JKA
- FDA submissions
- K944566
- Distribution
- Worldwide Distribution, including US Nationwide
Product description
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
Code information (models, lots, serial numbers)
UDI: (01)30382903680567
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Vacutainer® PST™ Gel & Lithium HeparinN (LH) 56 Units Blood Collection Tubes 368056Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall31 reports
Other devices under the same FDA submission
5 devices cleared under K944566 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BD Vacutainer® Sodium HeparinN (NH) 75 USP Units Blood Collection Tubes 367871Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection103 reports
- BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes 367874Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection55 reports
- BD Vacutainer® Sodium HeparinN (NH) 33 USP = 33 IU Blood Collection Tubes 367671Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection27 reports
- BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes 367878Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection24 reports
- BD Vacutainer® Sodium HeparinN Blood Collection Tubes 368037Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 82963).
- Z-2296-2019 · TerminatedBD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
- Z-2297-2019 · TerminatedBD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
- Z-2298-2019 · TerminatedBD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
- Z-2299-2019 · TerminatedBD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
- Z-2300-2019 · TerminatedBD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
- Z-2301-2019 · TerminatedBD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
- Z-2302-2019 · TerminatedBD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
- Z-2303-2019 · TerminatedBD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
- Z-2304-2019 · TerminatedBD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
- Z-2305-2019 · TerminatedBD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
- Z-2306-2019 · TerminatedBD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
- Z-2308-2019 · TerminatedBD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
- Z-2309-2019 · TerminatedBD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
- Z-2310-2019 · TerminatedBD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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