BD Vacutainer® Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes 366667Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 30382903666677), received between Apr 20, 2018 and Apr 22, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Short Fill” (10 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-2297-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Component Missing

  IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES WERE MISSING GEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24959827 ↗
• MalfunctionAug 3, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES LOW FILL VOLUME OCCURRED IN AT LEAST HALF OF THE TUBES OF 1 BOX. NO PATIENT IMPACT OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS LOW FILL VOLUMES IN AT LEAST HALF OF THE TUBES FROM 1 BOX OF LOT#: 2321348.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455484 ↗
• MalfunctionJul 15, 2022Positioning Problem; Separation Problem; Positioning Problem; Separation Problem

  IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES CUSTOMER STATES CAP POPS OFF TUBE BEFORE FILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER STATES CAP POPS OFF TUBE BEFORE FILLING..¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033042 ↗
• MalfunctionApr 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES. THE DEVICE EXPERIENCED ERRONEOUS RESULTS .THIS EVENT OCCURRED THREE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES ARE PRESENT ERRORS. "WE ARE STARTING TO SEE ERRORS ON OUR MACHINES WITH SPECIMENS DRAWN IN THOSE TUBES. LOT# 1350304 EXP 04-30-2023 3 SEPARATE TIMES 3 SEPARATE MACHINES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116319 ↗
• MalfunctionJul 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED INSUFFICIENT ADDITIVE QUANTITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE TUBE HAVE A LACK OF GEL IN THE BOTTOM OF THEM. CANNOT USE THESE LITHIUM TUBES DUE TO THE LACK OF GEL IN THE BOTTOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193638 ↗
• MalfunctionAug 11, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER USE THE RUBBER STOPPER REMAINED IN TUBE WITH A BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHE REPORTED THAT WHEN THE NURSES TRIED PULLING THE RUBBER STOPPER OUT OF THE TUBE, THEY WERE HAVING A DIFFICULT TIME DOING SO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394247 ↗
• MalfunctionFeb 10, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THE STOPPER WAS DIRTY.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9688831 ↗
• MalfunctionNov 26, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES HAD UNDERFILL. THIS OCCURRED ON 100 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 366667, BATCH NO. 9036727 - IT IS REPORTED CUSTOMER HAS EXPERIENCED UNDER FILLING WHILE USING VACUTAINERS. CUSTOMER IS STATING THAT THIS 3ML TUBE IS PERIODICALLY NOT FILLING TO THE FILL LINE ON THE LABEL. THEY DO NOT FEEL IT IS A LOT SPECIFIC ISSUE. THEY ARE INVESTIGATING INTERNALLY TO SEE IF THERE ARE PREANALYTICAL/DRAWING ISSUES THAT MAY BE A FACTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9375607 ↗
• MalfunctionAug 29, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBE UNDERFILLED DURING RESEARCH AND DEVELOPMENT TESTING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING, WE OBSERVED TUBES WITH A DRAW VOLUME BELOW OUR MINIMUM SPECIFICATION. CATALOG/BATCH NUMBER INFORMATION IS BELOW. CATALOG # BATCH # TEST DATE DATA REVIEW DATE 366667 9065768 (B)(6) 2019 (B)(6) 2019 368587 9065849 (B)(6) 2019 (B)(6) 2019 367981 9123804 (B)(6) 2019 (B)(6) 2019 367977 9116677 (B)(6) 2019 (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8945226 ↗
• MalfunctionJul 1, 2019Overfill; Overfill

  IT WAS REPORTED THAT 11 BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES EXPERIENCED OVERFILL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 366667 BATCH NO: 9095727 EVENT DESCRIPTION PER EMAIL STATES, DURING R&D TESTING IN FRANKLIN LAKES, WE HAVE IDENTIFIED INSTANCES WHERE THE TUBE DRAW VOLUME WAS OUTSIDE OF OUR SPECIFICATIONS. THE SPECIFIC PRODUCT SKU AND BATCH NUMBERS WHERE THIS OCCURRED ARE LISTED BELOW. EVENT DATE AWARENESS DATE CATALOG # BATCH # OBSERVATION (B)(6) 2019 (B)(6) 2019: (B)(6). DRAW VOLUMES ABOVE 3.3ML (SEVERAL TUBES WITH MAXIMUM DRAW 3.31ML).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748920 ↗
• MalfunctionOct 3, 2018Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH UNDERFILL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931630 ↗
• MalfunctionSep 27, 2018Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 56 USP UNITS BLOOD COLLECTION TUBES UNDER FILLED OR HAD LOW DRAW. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915714 ↗
• MalfunctionJun 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 56 USP UNITS BLOOD COLLECTION TUBES SHOWED FM IN THE TUBES. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7603523 ↗
• MalfunctionJun 12, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES HAD LOW VACUUM ISSUES. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594322 ↗
• MalfunctionJun 7, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 56 USP UNITS BLOOD COLLECTION TUBES WEREN¿T FILLING PROPERLY. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7580427 ↗
• MalfunctionMay 31, 2018Short Fill; Short Fill

  IT WAS REPORTED THE BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES WERE UNDER FILLING, NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7556898 ↗
• MalfunctionMay 15, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES WERE UNDER FILLING.

  Patient problems: No Information

  MAUDE report 7515007 ↗
• MalfunctionMay 14, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES HAD CLOTTING.

  Patient problems: No Information

  MAUDE report 7512941 ↗
• MalfunctionApr 20, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 56 USP UNITS BLOOD COLLECTION TUBES "HEPARIN-366667 - NO OR LOW DRAW."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7448717 ↗

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-2299-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
• Z-2296-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
• Z-2310-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
• Z-2298-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
• Z-2309-2019 · Jun 12, 2019 · Terminated
  BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884