BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes 367878Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 30382903678786), received between May 17, 2018 and Mar 24, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K252040, K944566); 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SODIUM HEPARINN (NH) 95 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 24679355 ↗
• MalfunctionMar 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SODIUM HEPARINN (NH) 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 24623795 ↗
• MalfunctionApr 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VACUTAINER® SODIUM HEPARINN (NH) 95 USP UNITS BLOOD COLLECTION TUBES, THERE WAS ERRONEOUS RESULTS WITH 1 TUBE WHEN DOING A KARYOTYPE ANALYSIS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862811 ↗
• MalfunctionJan 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED AFTER USING BD VACUTAINER® SODIUM HEPARINN (NH) 95 USP UNITS BLOOD COLLECTION TUBES FOR KARYOTYPING, ERRONEOUS RESULTS WERE SEEN IN 1 SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218395 ↗
• MalfunctionSep 27, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SODIUM HEPARINN (NH) 95 USP UNITS BLOOD COLLECTION TUBES THAT THE SHELF PACK INCLUDED TWELVE (12) LITHIUM HEPARIN TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325813 ↗
• MalfunctionJun 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BEFORE USE THE BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE HAD A BROKEN HEMOGARD CAP. THERE WAS NO REPORTED IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19487374 ↗
• MalfunctionApr 1, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES WERE USED PAST THE EXPIRATION DATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014021 ↗
• MalfunctionOct 31, 2023Coagulation in Device or Device Ingredient; Device Ingredient or Reagent Problem; Coagulation in Device or Device Ingredient; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES HAS ISSUES WITH HEMOLYSIS. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT LOT#: 3111828 WITH COAGULATION. THEY REPORT THAT " BLOOD THAT IS DRAWN GOES GLOSSY AND CANNOT BE USED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18043064 ↗
• MalfunctionDec 12, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES HAVE LOW DRAW VOLUME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958977 ↗
• MalfunctionNov 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WERE MOLDING DEFECT SHARP PROTRUSIONS. THIS EVENT WAS REPORTED TO HAVE AFFECTED 6000 DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE OUTER PACKAGE WAS OPENED, IT WAS FOUND THAT THE EDGE OF THE CAP OF THE GREEN TUBE HAD MISSING OR ROUGH EDGES, WHICH AFFECTED THE CLINICAL CUSTOMERS' USE AND THE ROUGH EDGES PIERCED THE CUSTOMERS' FINGERS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826741 ↗
• MalfunctionAug 11, 2022Filling Problem; Filling Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT TUBES ARE EXPERIENCING VACUUM ISSUES. BARBARA CARSON : (B)(6) 2022 15:34:04 (GMT) SM 367878, LOT #1137406 VACUUM ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15207605 ↗
• MalfunctionJul 2, 2021Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED INCORRECT ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PRIOR CONCERN REPORTED: WE NOTICED THAT THERE IS NO POWDERY WHITE SOLUTION IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12110516 ↗
• MalfunctionJun 28, 2021Component Missing; Component Missing

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES THERE WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "VACUTAINERS WE RECEIVED HAD NO ADDITIVES. FOUR CASES (400 VIALS) WERE RECEIVED WITH NO POWDERY WHITE SOLUTION IN THEM. THE LAB INFORMED US THE BLOOD SAMPLES SENT LAST WEEK WERE ALL BAD. THAT¿S WHEN WE NOTICED THAT ALL THE VIALS ARE EMPTY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081334 ↗
• MalfunctionNov 2, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE FOLLOWING ISSUE WAS FOUND IN TUBES (367929) FROM LOT 0072531: SPOT IN TUBE X2."

  Patient problems: No Patient Involvement

  MAUDE report 10773265 ↗
• InjuryAug 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE IT IS DIFFICULT TO DISTINGUISH BETWEEN SODIUM AND LITHIUM HEPARIN TUBES WITH A BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES. THERE WAS NO REPORTED IMPACT TO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS) WE UTILIZE BOTH THE SODIUM AND THE LITHIUM HEPARIN TUBES IN ONCOLOGY. WE USE THE SODIUM HEPARIN FOR THE FOLLOWING TESTS: FLOW CYTOMETRY ONLY: LEUKEMIA/LYMPHOMA PHENOTYPING BY MULTI-COLOR FLOW CYTOMETRY FOR PERIPHERAL BLOOD. FLOWCYTOMETRY ONLY: LEUKEMIA/LYMPHOMA PHENOTYPING BY MULTI-COLOR FLOW CYTOMETRY FOR BONE MARROW ASPIRATES. CHROMOSOME ANALYSIS - PERIPHERAL BLOOD/PUBS FOR CONSTITUTIONAL STUDIES. CHROMOSOME ANALYSIS - NEOPLASTIC (HEMATOLOGICAL MALIGNANCIES, LEUKEMIA). HOWEVER, AS WE ALSO HAVE THE LITHIUM TUBES ON THE FLOOR, THERE HAVE BEEN 2-3 INSTANCES IN THE LAST TWO TO THREE WEEKS WHERE THE TEAM HAS USED THE INCORRECT TUBE, LEADING TO AN ADDITIONAL STICK OR BONE MARROW ASPIRATE DESPITE MESSAGING TO LOOK FOR THE STRIPES TO INDICATE THE SODIUM HEPARIN AND TO CAREFULLY READ THE TUBE LABEL. WE FEEL THAT ENSURING THAT THE TUBES LOOK DIFFERENT WOULD HELP MITIGATE THESE ERRORS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417759 ↗
• MalfunctionApr 16, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL ON THE BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBE HAD PARTIALLY PEELED OFF BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLASTIC ENCAPSULATES TEAR PRODUCT = 1 SP AND OPEN LABEL = 1 SP".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9968447 ↗
• MalfunctionMar 23, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BEFORE USE THE BD VACUTAINER® LITHIUM HEPARIN (LH) 158 USP UNITS BLOOD COLLECTION TUBES HAD LABEL LIFT OFF/PARTIAL PEEL OFF. THIS OCCURRED 25 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OPEN LABEL".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9869236 ↗
• MalfunctionMar 3, 2020Device Markings/Labelling Problem; Device Contamination with Chemical or Other Material; Device Markings/Labelling Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 1 BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBE HAD A "BLACK POINT" OF FOREIGN MATTER IN IT, AND 9 TUBES HAD LABEL PEEL OFF. ALL DEFECTS WERE FOUND BEFORE USE IN LOT# 9260592. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK POINT = 1 / OPEN LABEL = 9".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9781870 ↗
• MalfunctionFeb 25, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBE LABELS WERE LIFTING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OPEN LABEL".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9750933 ↗
• MalfunctionSep 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBE EXPERIENCED CONFUSION BETWEEN NAHEP AND LIHEP TUBES PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367878, BATCH NO: UNKNOWN. CUSTOMERS COMPLAINS THAT IT IS DIFFICULT TO DISTINGUISH BETWEEN THE 4ML SODIUM AND LITHIUM HEPARIN TUBES SINCE THE STOPPERS ARE IDENTICAL. THEY WOULD PREFER TO HAVE SOME TYPE OF DIFFERENTIATING FEATURE ON THE STOPPER TO AVOID CONFUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9135698 ↗
• MalfunctionJun 24, 2019Incorrect, 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 HAD ISSUES WITH THE CELL HARVEST YIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367878 BATCH NO: 8061712 IT WAS REPORTED THE CUSTOMER EXPERIENCED SOME ISSUES WITH THE CELL HARVEST YIELD. DESCRIPTION OF EVENT: OUR LABORATORY HAS BEEN EXPERIENCING SOME ISSUES WITH THE CELL HARVEST YIELD THEY WERE GETTING FROM BONE MARROW AND PERIPHERAL BLOOD SAMPLES FOR CHROMOSOME ANALYSIS. THEY RECENTLY DID A LARGE BATCH OF TESTING AND NOTED THAT ALL THE AFFECTED SAMPLES HAD A CORRESPONDING LOT # CLOSE TO EXPIRY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8727875 ↗
• MalfunctionJun 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES HAD "FOREIGN MATTER" NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7591370 ↗
• MalfunctionMay 29, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 158 USP UNITS BLOOD COLLECTION TUBES HAD "ERRONEOUS RESULTS".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7548910 ↗
• MalfunctionMay 17, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 158 USP UNITS BLOOD COLLECTION TUBES HAD MISSING ADDITIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7523955 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K252040, K944566. One submission often covers many models, so check the product and lot details in each record.

• Z-2307-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
• Z-2306-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036