BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes 368494Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 30382903684947), received between Dec 11, 2018 and Dec 12, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Short Fill” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Short Fill; Short Fill

  IT WAS REPORTED BEFORE USING THE BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES, (30) TUBES WERE FOUND WITH INSUFFICIENT NEGATIVE PRESSURE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796419 ↗
• MalfunctionDec 11, 2025Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® LH (LITHIUM HEPARIN) 34 I.U. PLUS BLOOD COLLECTION, FIFTY (50) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780461 ↗
• MalfunctionAug 6, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® LH (LITHIUM HEPARIN) PLUS BLOOD COLLECTION TUBES, ONE TUBE WITH AN INCORRECT LABEL WAS FOUND IN A TRAY OF GLUCOSE TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731483 ↗
• MalfunctionApr 17, 2024Material Separation; Material Separation

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH (LITHIUM HEPARIN) 34 I.U. PLUS BLOOD COLLECTION TUBES, THE STOPPER PULLED OUT OF THE TUBE AND REMAINED IN THE HOLDER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125120 ↗
• MalfunctionDec 1, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® LH (LITHIUM HEPARIN) 34 I.U. PLUS BLOOD COLLECTION TUBE HAD A LOSS OF VACUUM IN THE TUBES. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250887 ↗
• MalfunctionDec 11, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A BD¿ TUBE MEDIA TUBE LIHEP PLH HAD A CAP WITH A LIGHTER GREEN COLOR. THE COLOR WAS TOO LIGHT, SIMILAR TO THE GREY CAP. "THIS MAKES THE INPECO TRACK THE LIHEP TUBE NO LONGER RECOGNIZES, PLACES IT IN AN ERROR RACK AND ANALYSIS IS POSTPONED. THIS REDUCES THE TAT AND THE TIME TO RESULT, WHICH RESULTS IN DELAYS IN DIAGNOSING PATIENTS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8152057 ↗

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-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
• 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-2296-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
• Z-2298-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880