BD Vacutainer® Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes 367880Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30382903678809), received between May 3, 2018 and May 9, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Short Fill” (2 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.

Recalls naming this device

1. 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-2298-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2024Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES AN UNSPECIFIED NUMBER OF TUBES WERE UNDERFILLING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280145 ↗
• MalfunctionMay 21, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT IS REPORTED CUSTOMER IS EXPERIENCING UNDER FILLING. VERBIAGE RECEIVED, - "LITHIUM HEPARIN TUBES (LOT 9126505) VACUUM IS ONLY FILLING THE VACUTAINERS WITH 1/3 TO 1/2 THE VOLUME OTHER LITHIUM HEPARIN TUBES FROM OTHER LOTS. I HAVE A TRAY OF THESE TUBES IF YOU WOULD LIKE THEM. IMPACTS INTERNAL BDTI RESEARCH PROJECTS""

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866317 ↗
• MalfunctionJun 10, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367880 BATCH NO: UNKNOWN. IT WAS REPORTED THE INFORMATION ON THE UNIT LABEL IS DIFFERENT FROM WHAT IS ONLINE. WE TYPICALLY ORDER THESE BD TUBES FROM VWR AND HAVE NOTICED THAT ALTHOUGH THE PN IS THE SAME FOR EACH, THE UNITS OF LIHEP STATED ON THE PACKAGE LABEL (ORDERED FROM VWR) IS DIFFERENT THAN WHAT IS STATED ON THE BD WEBSITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8683807 ↗
• MalfunctionMay 16, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT BLOOD DRAWN FROM A PIG INTO THE BD VACUTAINER® LITHIUM HEPARIN (LH) 158 USP UNITS BLOOD COLLECTION TUBE CLOTTED AFTER INVERTING THE TUBE "SEVERAL TIMES". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "(B)(6) 2019 SPOKE WITH THE CUSTOMER. HE WORKS WITH PIGS AND ONE TUBE THAT HE DREW THIS MORNING CLOTTED AFTER HE INVERTED THE TUBE "SEVERAL TIMES." I EXPLAINED THAT WE DO NOT HAVE ANY DATA ON ANIMAL TESTING WITH THE BD VACUTAINERS. HE DISCARDED THE TUBES AND DID NOT TEST THEM."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8615686 ↗
• MalfunctionJul 26, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES EXHIBITED ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7723720 ↗
• MalfunctionMay 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD VACUTAINER® LITHIUM HEPARIN (LH) 158 USP UNITS BLOOD COLLECTION TUBES WERE DIRTY.

  Patient problems: No Information

  MAUDE report 7484815 ↗

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-2310-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
• Z-2309-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
• Z-2296-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
• Z-2297-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
• Z-2299-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884