BD Vacutainer® Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes 367886Recalls & reported problems
Becton, Dickinson And Company · TUBE LIHEP PLH 13X100 6.0 PLBL GN · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These BD Vacutainer lithium heparin tubes are used to collect blood samples for laboratory testing. Of its 279 reports, 277 are malfunction reports, mostly describing underfilled tubes and foreign matter or clotting inside them. Reports fell to 24 in the last 12 months from 58 before. One closed recall, from June 2019, covered falsely high carboxyhemoglobin results when used with 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
- 280
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 30382903678861), received between Dec 6, 2017 and Sep 23, 2026 — classified as 2 injuries, 278 malfunctions.
The most frequently reported specific device problem is “Short Fill” (154 reports).
1 FDA recall record name this device's identifier.
6 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
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-2300-2019 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Short Fill154
- Volume Accuracy Problem96
- Device Contamination with Chemical or Other Material28
- Coagulation in Device or Device Ingredient15
- Material Deformation14
- Leak/Splash13
- Difficult to Insert11
- Incorrect, Inadequate or Imprecise Result or Readings8
Patient problems
- No Clinical Signs, Symptoms or Conditions175
- No Consequences Or Impact To Patient73
- No Known Impact Or Consequence To Patient29
- No Patient Involvement2
- Exposure to Body Fluids1
- Insufficient Information1
- No Code Available1
- No Information1
Recent adverse event reports
The 25 most recent of 280 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Short Fill
It was reported while using BD Vacutainer® Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, one tube exhibited slow fill. A new tube was used and blood flowed normally. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867849 ↗MalfunctionSep 9, 2026Microbial Contamination of Device
It was reported during performance validation/testing while using BD Vacutainer® Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, microbial contamination was found inside 10 tubes. There was no health impact or consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692443 ↗MalfunctionMay 26, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 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 25280517 ↗MalfunctionMay 13, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, THE TUBE OF ONE PATIENT SAMPLE UNDERFILLED RESULTING IN RECOLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166465 ↗MalfunctionMay 6, 2026Short Fill
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 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 25094926 ↗MalfunctionMay 6, 2026Short Fill
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 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 25094919 ↗MalfunctionMay 4, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® LITHIUM HEPARIN (LH) 95 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 25075597 ↗MalfunctionMay 4, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, FOREIGN MATTER WAS SEEN INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25072347 ↗MalfunctionMay 1, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, FOREIGN MATTER WAS SEEN INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059409 ↗MalfunctionApr 29, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® LITHIUM HEPARIN (LH) 95 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 25029675 ↗MalfunctionApr 23, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, A FOREIGN OBJECT (A GREEN PLASTIC PIECE) WAS SEEN INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971676 ↗MalfunctionApr 21, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARIN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, ONE (1) TUBE LEAKED FROM A CRACK IN THE BOTTOM OF THE TUBE. THE TUBE WAS REPLACED AND DRAW CONTINUED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24946837 ↗MalfunctionApr 8, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES FOREIGN MATTER WAS SEEN INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817141 ↗MalfunctionMar 30, 2026Fluid/Blood Leak
IT WAS REPORTED AFTER USING BD VACUTAINER® LITHIUM HEPARIN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, BLOOD LEAKED FROM THE CAP OF ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24736478 ↗MalfunctionFeb 17, 2026Crack
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, THE BOTTOM OF ONE TUBE WAS CRACKED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368838 ↗MalfunctionJan 27, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, DEBRIS WAS OBSERVED IN THE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192567 ↗MalfunctionDec 22, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD, THERE WAS A PROTRUDING PLASTIC SPIKE INSIDE THE TUBE OF 20 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23871886 ↗MalfunctionDec 19, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD, ONE (1) TUBE UNDERFILLED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851347 ↗MalfunctionDec 17, 2025Separation Problem; Separation Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, 2 TUBES HAD COCKED STOPPERS RESULTING IN UNDERFILLED TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23832184 ↗MalfunctionNov 24, 2025Clumping in Device or Device Ingredient; Improper Chemical Reaction; Clumping in Device or Device Ingredient; Improper Chemical Reaction
IT WAS REPORTED AFTER CENTRIFUGING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, 10 SAMPLES CONTAINED FIBRIN CLUSTERS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23635105 ↗MalfunctionNov 24, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED AFTER CENTRIFUGING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, 30 SAMPLES CONTAINED FIBRIN CLUSTERS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633405 ↗MalfunctionNov 19, 2025Improper Chemical Reaction; Improper Chemical Reaction
REPORT 2 OF 3: IT WAS REPORTED AFTER USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, 45% OF SAMPLES ANALYZED CONTAINED FIBRIN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23600540 ↗MalfunctionNov 19, 2025Improper Chemical Reaction; Improper Chemical Reaction
REPORT 1 OF 3. IT WAS REPORTED AFTER USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, 59% OF SAMPLES ANALYZED CONTAINED FIBRIN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23600510 ↗MalfunctionNov 19, 2025Improper Chemical Reaction; Improper Chemical Reaction
REPORT 3 OF 3: IT WAS REPORTED AFTER USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, 69% OF SAMPLES ANALYZED CONTAINED FIBRIN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23600499 ↗MalfunctionNov 11, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES, THERE WAS TUBE PUSH OFF SEEN WITH 20 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528800 ↗
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 · TerminatedBD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
- Z-2298-2019 · Jun 12, 2019 · TerminatedBD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
- Z-2310-2019 · Jun 12, 2019 · TerminatedBD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
- Z-2296-2019 · Jun 12, 2019 · TerminatedBD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
- Z-2297-2019 · Jun 12, 2019 · TerminatedBD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
- Z-2299-2019 · Jun 12, 2019 · TerminatedBD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
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- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall747 reports
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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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