BD Vacutainer® Lithium HeparinN (LH) 75 USP Units Blood Collection Tubes 367884Recalls & reported problems

Becton, Dickinson And Company · TUBE LIHEP PLH 13X75 4.0 PLBL GN · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This BD Vacutainer lithium heparin blood collection tube has 271 reports, with no deaths and 2 injuries. Many describe tubes that are underfilled or clotting, and some describe leaks, inaccurate results, or contamination. One recall, which began in June 2019 and is closed, concerns falsely high blood carbon monoxide readings on one blood gas analyzer.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 269
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 30382903678847), received between Nov 27, 2017 and Sep 15, 2026 — classified as 2 injuries, 267 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (59 reports).

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K901449); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Jun 12, 2019Class IITerminated
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.
Z-2299-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

Incorrect, Inadequate or Imprecise Result or Readings59
Short Fill55
Leak/Splash28
Device Contamination with Chemical or Other Material26
Volume Accuracy Problem23
Difficult to Insert18
Material Deformation18
Device Markings/Labelling Problem16

Patient problems

No Clinical Signs, Symptoms or Conditions139
No Known Impact Or Consequence To Patient102
No Consequences Or Impact To Patient13
No Patient Involvement6
Hemolysis3
No Information3
Exposure to Body Fluids2
No Code Available2

Recent adverse event reports

The 25 most recent of 269 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 15, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780204 ↗
MalfunctionSep 11, 2026Short Fill
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736915 ↗
MalfunctionMay 20, 2026Improper Chemical Reaction
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES ARE CLOTTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233875 ↗
MalfunctionMay 11, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, 2 TUBES UNDERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25141808 ↗
MalfunctionMay 5, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087625 ↗
MalfunctionApr 21, 2026Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARIN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, ONE (1) TUBE WAS MISSING A LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24947992 ↗
MalfunctionApr 3, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARIN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774872 ↗
MalfunctionFeb 24, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434793 ↗
MalfunctionFeb 17, 2026Material Deformation
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, THE STOPPER WAS COCKED IN ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24373050 ↗
MalfunctionFeb 5, 2026Premature Separation
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BCT, STOPPER POP OFF OCCURRED AN UNSPECIFIED NUMBER OF TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273086 ↗
MalfunctionFeb 5, 2026Premature Separation
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, 1 TUBE HAD DEFECTIVE STOPPER MOLDING AND WAS SIDEWAYS IN THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268765 ↗
MalfunctionJan 27, 2026Difficult to Insert
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, TUBE PUSH OFF OCCURRED ON TWENTY (20) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192741 ↗
MalfunctionDec 10, 2025Separation Problem; Separation Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD, A NEUROSURGERY NURSE ENCOUNTERED A NEEDLE AND BLOOD COLLECTION TUBE SEPARATION DURING PATIENT PHLEBOTOMY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772616 ↗
MalfunctionDec 4, 2025Separation Failure; Separation Failure
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, 1 TUBE EXHIBITED CLOSURE SEPARATION ON THEIR AUTOMATED INSTRUMENT WHERE THE SHIELD AND STOPPER SEPARATED UPON REMOVAL LEAVING THE STOPPER IN THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23722393 ↗
MalfunctionDec 3, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, THERE WAS TUBE PUSH OFF SEEN WITH ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23711551 ↗
MalfunctionDec 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, FOREIGN MATTER- CLEAR LIQUID WAS FOUND IN ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700387 ↗
MalfunctionNov 18, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23589736 ↗
MalfunctionNov 13, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN TWO (2) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23546799 ↗
MalfunctionNov 6, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, THERE WAS TUBE PUSH OFF AFTER FILLING A CERTAIN VOLUME IN ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490587 ↗
MalfunctionOct 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23343432 ↗
MalfunctionOct 15, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23304664 ↗
MalfunctionSep 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, THERE WAS ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058297 ↗
MalfunctionAug 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 2: IT WAS REPORTED AFTER USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, ERRONEOUS RESULTS CALCIUM WAS SEEN IN ONE (1) SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22755859 ↗
MalfunctionAug 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 2. IT WAS REPORTED AFTER USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, ERRONEOUS RESULTS-CALCIUM WAS SEEN IN ONE (1) SAMPLE. SAMPLE WAS REDRAWN AND RESULTS WERE IN A NORMAL RANGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22755825 ↗
MalfunctionJul 29, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 75 USP UNITS BLOOD COLLECTION TUBES, THERE WAS TUBE PUSH OFF LEADING TO UNDERFILL WITH THIRTY (30) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22640138 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K901449. One submission often covers many models, so check the product and lot details in each record.

Z-2309-2019 · Jun 12, 2019 · Terminated
BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
Z-2310-2019 · Jun 12, 2019 · Terminated
BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
Z-2298-2019 · Jun 12, 2019 · Terminated
BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
Z-2297-2019 · Jun 12, 2019 · Terminated
BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
Z-2296-2019 · Jun 12, 2019 · Terminated
BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664

Device details

UDI-DI	`30382903678847`
Brand	BD Vacutainer® Lithium HeparinN (LH) 75 USP Units Blood Collection Tubes
Model	367884
Company	Becton, Dickinson And Company
Product code	JKA · Tubes, vials, systems, serum separators, blood collection
Class	Class 2
FDA submission	K901449
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 4, 2024

Device type (GMDN): Evacuated blood collection tube IVD, anticoagulant

A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and an anticoagulant [e.g., sodium heparin, sodium citrate, potassium oxalate, ethylenediaminetetraacetic acid (EDTA)]. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood lead, toxicology, nutritional-chemistry, and other plasma chemistry determinations). This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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