BD Vacutainer® Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes 366664Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 30382903666646), received between Apr 23, 2018 and Jan 28, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Short Fill” (13 reports).

2 FDA recall records name this device's identifier.

4 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-2296-2019 · Root cause: Device Design · Recall details · FDA record ↗

2. 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-2310-2019 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionJan 28, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES, 7 TUBES UNDERFILLED. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203745 ↗
• MalfunctionFeb 16, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES AN UNSPECIFIED NUMBER OF TUBES WERE UNDERFILLING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSES AT THE FACILITY ARE HAVING ISSUES FILLING TUBE ITEM # 366664, LOT#1319199. ACCORDING TO THE SUPERVISOR OF OPS AT THE FACILITY, THEY WERE ONLY ABLE TO GET A COUPLE DROPS FROM THEIR PATIENTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387447 ↗
• MalfunctionOct 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING AN UNKNOWN BD¿ PRODUCT BLOOD COLLECTION TUBE THE CUSTOMER IS EXPERIENCING ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿TUBES ARE EXPERIENCING ERRONEOUS RESULTS. MULTIPLE GREEN TOP TUBES ARE SHOWING ERRORS IN RESULTS CAUSING BIAS IN TESTING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538591 ↗
• MalfunctionJul 7, 2022Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES THAT THE STOPPER POPPED OUT OF THE TUBES. THE FOLLOWING STATEMENT WAS PROVIDED BY THE INITIAL REPORTER: "STOPPERS POPPING OUT OF TUBES DURING BAGGED TRANSPORT TO THE LAB"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14950652 ↗
• MalfunctionFeb 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED HEMOLYSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT PATIENTS' LABS ARE REJECTING. UPDATE: SAMPLES ARE HEMOLYZED. "THEY HAVE 9PKS LEFT BUT PULLED FROM UNITS AS NURSES REPORTED PATIENTS' LABS WERE REJECTING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13461695 ↗
• MalfunctionOct 4, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE TUBE LIHEP PLH 13X75 2.0 PLBL GN, 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 THAT TUBES ARE UNDERFILLING. CUSTOMER CLAIMS TUBES ARE NOT FILLING TO THE WHITE LINE ON THE LABEL. ED STATES THE TUBES STOP FILLING AUTOMATICALLY BETWEEN 1-1.5ML RESULTING IN SHORT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568265 ↗
• MalfunctionJun 4, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS 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: WE ARE SEEING THE SAME PROBLEM WITH THE PEDIATRIC LITHIUM HEPARIN TUBES NOT FILLING TO THE MARK. WE CURRENTLY HAVE THE TUBES TAKEN OUT OF CIRCULATION AS OUR PEDIATRIC TUBES NEED TO BE FILLED FOR ALL OF OUR BLOOD GASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941342 ↗
• MalfunctionJun 4, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBE, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE ARE SEEING THE SAME PROBLEM WITH THE PEDIATRIC LITHIUM HEPARIN TUBES NOT FILLING TO THE MARK. WE CURRENTLY HAVE THE TUBES TAKEN OUT OF CIRCULATION AS OUR PEDIATRIC TUBES NEED TO BE FILLED FOR ALL OF OUR BLOOD GASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941293 ↗
• MalfunctionMay 25, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) (B)(4) USP UNITS BLOOD COLLECTION TUBES UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT TUBES ARE UNDERFILLING. CUSTOMER CALLED TO SEE WHAT THE FILL VOLUMES ARE FOR TUBES, SHE IS REPORTING THAT TUBES ARE UNDERFILLING. ISSUE HAS OCCURRED A COUPLE OF TIMES. NO KNOWN DATE. THIS IS A NEW TUBE AND THEY NEED SOME CLARIFICATION ON THE DRAW VOLUME. SAMPLES ARE AVAILABLE. TUBES ARE FILLING TO ABOUT 0.5 ML SHORT OF THE 2ML."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881499 ↗
• MalfunctionFeb 24, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THE BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES THE CLIENT EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING POST MARKET SURVEILLANCE ACTIVITY PHONE CALL, CUSTOMER COMPLAINED OF HAVE FREQUENT SAMPLE UNDERFILL ON BD VACUTAINER ®SODIUM FLUORIDE TUBE, BD VACUTAINER ®LITHIUM HEPARIN TUBE, AND BD VACUTAINER ®EDTA TUBE. SHE MENTIONED THAT THE FLUORIDE TUBE HAS 2021-03-31 EXPIRATION DATE, THE LITHIUM HEPARIN TUBE HAS JUNE 2021 EXPIRATION, BUT DID NOT PROVIDE REFERENCE NUMBERS OR LOT NUMBER FOR ANY OF THE TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11376196 ↗
• MalfunctionSep 19, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT UNDERFILL OCCURRED DURING USE WITH A BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE TUBES ARE UNDER FILLING. HELLO. IT HAS COME TO OUR ATTENTION THAT ONE OF OUR SITES IS HAVING SUBSTANTIAL PROBLEMS WITH THE SOFT DRAW TUBES. THEY ARE REPORTING UNDERFILLING (ONLY 2/3 FULL) INCLUDING THE GREEN AND LAVENDER. THIS IS MOSTLY A PROBLEM WHEN USING A BUTTERFLY. THE SITE CONFIRMED THAT THEY ARE USING THE CLEAR DISCARD TUBE TO CLEAR THE BUTTERFLY TUBING FIRST AND THEN THE FLOW STOPS ONCE THE SOFT DRAW TUBES ARE ATTACHED. WE ARE LOOKING INTO THE TYPE OF ADAPTER THEY ARE USING FOR THE TUBES TO SEE IF THIS COULD BE THE REASON." THIS IS 1 OF 7 COMPLAINTS, AND CAPTURES THE EVENT THAT OCCURRED (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9088226 ↗
• MalfunctionSep 17, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  MATERIAL NO. 366664. BATCH NO. UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES THE TUBES ARE UNDER FILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT HAS COME TO OUR ATTENTION THAT ONE OF OUR SITES IS HAVING SUBSTANTIAL PROBLEMS WITH THE SOFT DRAW TUBES. THEY ARE REPORTING UNDERFILLING (ONLY 2/3 FULL) INCLUDING THE GREEN AND LAVENDER. THIS IS MOSTLY A PROBLEM WHEN USING A BUTTERFLY. THE SITE CONFIRMED THAT THEY ARE USING THE CLEAR DISCARD TUBE TO CLEAR THE BUTTERFLY TUBING FIRST AND THEN THE FLOW STOPS ONCE THE SOFT DRAW TUBES ARE ATTACHED. WE ARE LOOKING INTO THE TYPE OF ADAPTER THEY ARE USING FOR THE TUBES TO SEE IF THIS COULD BE THE REASON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9076372 ↗
• MalfunctionSep 5, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES ARE UNDERFILLING. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(4). BATCH NO: UNKNOWN (POSSIBLE 8249993, 9065767). IT WAS REPORTED THE TUBES ARE UNDERFILLING. IT HAS COME TO OUR ATTENTION THAT ONE OF OUR SITES IS HAVING SUBSTANTIAL PROBLEMS WITH THE SOFT DRAW TUBES. THEY ARE REPORTING UNDERFILLING (ONLY 2/3 FULL) INCLUDING THE GREEN AND LAVENDER. THIS IS MOSTLY A PROBLEM WHEN USING A BUTTERFLY. THE SITE CONFIRMED THAT THEY ARE USING THE CLEAR DISCARD TUBE TO CLEAR THE BUTTERFLY TUBING FIRST AND THEN THE FLOW STOPS ONCE THE SOFT DRAW TUBES ARE ATTACHED. WE ARE LOOKING INTO THE TYPE OF ADAPTER THEY ARE USING FOR THE TUBES TO SEE IF THIS COULD BE THE REASON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8967180 ↗
• MalfunctionJun 19, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CASE OF MATERIAL # 366664 BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES HAD A MATERIAL # 367983 LABELED TUBE IN IT FOUND BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I FOUND AN CASE THAT HAD A DIFFERENT ITEM IN IT." THE CUSTOMER RECEIVED INCORRECT MATERIAL - NOT ON PO & MATERIAL PACKED WAS NOT PER LABEL. LABELED 367983, PACKED 366664. THIS IS NOT CLAIMS RELATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8713403 ↗
• MalfunctionJun 22, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® LITHIUM HEPARIN (LH) 37 USP UNITS BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH A DIFFICULT ERRONEOUS RESULTS. IT WAS STATED ¿NEGATIVE BIAS WITH IONIZED CALCIUM.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7631093 ↗
• MalfunctionJun 12, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 37 USP UNITS BLOOD COLLECTION TUBES HAD "ERRONEOUS RESULTS." NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594670 ↗
• MalfunctionJun 7, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 37 USP UNITS BLOOD COLLECTION TUBES WERE EXPERIENCING LOW DRAWS.

  Patient problems: No Information

  MAUDE report 7579796 ↗
• MalfunctionJun 7, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 37 USP UNITS BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7578756 ↗
• MalfunctionJun 5, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® LITHIUM HEPARIN (LH) 37 USP UNITS BLOOD COLLECTION TUBES WERE UNDERFILLING AND THE VACUUM WAS NOT WORKING PROPERLY. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7571295 ↗
• MalfunctionJun 5, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 37 USP UNITS BLOOD COLLECTION TUBES WERE GETTING AIR BUBBLES AND FIBRIN IN THEM. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7570103 ↗
• MalfunctionJun 4, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT DURING USE THE BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES WERE ONLY FILLING HALF WAY. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7566143 ↗
• MalfunctionMay 31, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES HAD HIGHER THAN NORMAL READINGS OF PO2 AND OXYGEN SATURATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7557328 ↗
• MalfunctionMay 10, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® LITHIUM HEPARIN (LH) 37 USP UNITS BLOOD COLLECTION TUBES WERE NOT DRAWING OVER 2ML.

  Patient problems: No Information

  MAUDE report 7505044 ↗
• MalfunctionApr 23, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE WAS A SMEAR ATTACHED TO THE CAP OF BD VACUTAINER® LITHIUM HEPARIN (LH) 37 USP UNITS BLOOD COLLECTION TUBES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7451350 ↗

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