BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes 368884Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 30382903688846), received between Oct 25, 2023 and Feb 4, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Short Fill” (6 reports).

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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES HAVE ISSUES FILLING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261895 ↗
• MalfunctionSep 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBE PACKS WERE MISSING THE CH-REP LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946531 ↗
• MalfunctionAug 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) PLUS BLOOD COLLECTION TUBES, FALSE POSITIVE TROPONIN RESULTS WERE OBTAINED ON AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22844027 ↗
• MalfunctionAug 15, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) PLUS BLOOD COLLECTION TUBES, THERE IS LESS VACUUM IN AN UNSPECIFIED NUMBER OF TUBES AND TAKES LONGER THAN ONE MINUTE TO FILL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816208 ↗
• MalfunctionJul 28, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, 10 TUBES HAVE CLOTTED EVEN THOUGH THEY SHOULDN'T. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631339 ↗
• MalfunctionJul 15, 2025Separation Problem; Separation Problem

  REPORT 2 OF 2, IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, THE STOPPER OF ONE TUBE POPPED OFF RESULTING IN SAMPLE LEAKAGE AND EXPOSURE TO BLOOD ON THE MANAGER'S HANDS AND THE BENCH. THE LEVEL OF PPE WORN IS UNKNOWN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22513091 ↗
• MalfunctionJul 15, 2025Short Fill; Premature Separation; Short Fill; Premature Separation

  REPORT 1 OF 2, IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES HAD LOOSE CAPS AND ONE TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22513057 ↗
• MalfunctionMay 19, 2025Short Fill; Short Fill

  REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS 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 22045631 ↗
• MalfunctionMay 19, 2025Short Fill; Short Fill

  REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS 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 22045629 ↗
• MalfunctionNov 19, 2024Difficult to Insert; Short Fill; Difficult to Insert; Short Fill

  IT WAS REPORTED WHEN USING AN UNSPECIFIED NUMBER OF BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, THE DEVICE PUSHED OFF THE CONNECTED ACQUISITION DEVICE AND FILLING WAS INCOMPLETE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724658 ↗
• MalfunctionOct 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES THAT ONE (1) SAMPLE PROVIDED AN ABNORMAL POTASSIUM RESULT. THE SAMPLE WAS RECOLLECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552254 ↗
• MalfunctionJul 25, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES AN UNSPECIFIED NUMBER OF TUBES PUSHED OFF THE NON-PATIENT ACQUISITION NEEDLE END DURING COLLECTION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824445 ↗
• MalfunctionMar 28, 2024Defective Component; Device Contamination with Chemical or Other Material; Defective Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES THAT THERE WAS FOREIGN MATTER AND A SHIELD MOLDING DEFECT IN ONE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991384 ↗
• MalfunctionOct 25, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBES, SAMPLES CLOTTED. THIS OCCURRED 10 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: THESE TUBES ARE CENTRIFUGED, THEN SCANNED AND PHOTOGRAPHED THEN THEY ARE SENT TO OUR ANALYTICAL LINES, WHERE THE MACHINE DETECTS A ¿CLOT¿ SO NOTHING IS TAKEN OR ANALYZED AND A TECHNICAL ALARM IS GENERATED WHICH GENERATES SIGNIFICANT DELAYS FOR THESE SAMPLES. WHEN WE COLLECTED THE TUBE ABOUT THIRTY MINUTES LATER BY HAND, THE FOAM WAS STILL PRESENT. FOR YOUR INFORMATION, WE WORK WITH ROCHE AUTOMATS, AND OUR TUBES CIRCULATE ON 5-POSITION RACKS. THE OTHER TUBES IN THE RACK DID NOT HAVE THIS FOAM, SO A JOLT ON THE CONVEYOR AFTER CENTRIFUGATION SEEMS UNLIKELY TO ME AS WELL. ARE THERE CLOTS OR FIBRIN FOUND IN THE SAMPLES OR JUST THE INSTRUMENT INDICATING ¿CLOT¿? THE SAMPLE IS FOAMING/SHOWING BUBBLES ON TOP OF THE PLASMA. THESE BUBBLES ARE PERCEIVED AS A CLOT BY THE INSTRUMENT. WHEN IT STATES: ¿THE FOAM WAS STILL PRESENT¿ ¿ IS THIS THE ISSUE THAT NEEDS TO BE REPORTED? ARE THERE BUBBLES IN THE SAMPLE? THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007771 ↗

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