BD Vacutainer® C&S Preservative Urine Tube 364951Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 50382903649513), received between Nov 27, 2017 and May 5, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K024240); 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. May 25, 2022Class IIOpen, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1617-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Short Fill; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® C&S PRESERVATIVE URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED AN INADEQUATE AMOUNT OF ADDITIVE IN THEM TO STABILIZE THE URINE AS WELL AS INSUFFICIENT VACUUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086186 ↗
• MalfunctionApr 14, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® C&S PRESERVATIVE URINE TUBE, FOUR TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879105 ↗
• MalfunctionApr 14, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® C&S PRESERVATIVE URINE TUBE, AN INCORRECT EXPIRATION DATE APPEARED ON AN UNSPECIFIED NUMBER OF PACKAGES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. UPDATE: PER ADDITIONAL INFORMATION RECEIVED FROM THE REGION, THERE IS NO COMPLIANCE ISSUE RELATED TO THE LABELING. THIS EVENT DOES NOT MEET THE DEFINITION OF A COMPLAINT AND WILL BE CLOSED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879095 ↗
• MalfunctionApr 14, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® C&S PRESERVATIVE URINE TUBE, FIVE TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873626 ↗
• MalfunctionNov 5, 2025Separation Problem; Separation Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® C&S PRESERVATIVE URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT STOPPER PULLOUT WHEN USED WITH A TRANSFER STRAW. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478632 ↗
• MalfunctionSep 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED FROM A LITERATURE REVIEW DURING A STUDY USING BD VACUTAINER® C&S PRESERVATIVE URINE TUBE, GRAM-POSITIVE BACTERIA ARE NOT STABLE AT 48 HOURS WHICH CONTRADICTS INSTRUCTION FOR USE(IFU) WHICH CLAIMS STABILITY UP TO 48 HOURS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959888 ↗
• MalfunctionAug 27, 2025Separation Problem; Separation Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® C&S PRESERVATIVE URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES EXHIBIT STOPPER PULL OUT WHEN USED WITH A URINE STRAW EXPOSING THE NEEDLE FROM THE STRAW. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909006 ↗
• MalfunctionMay 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD VACUTAINER® C&S PRESERVATIVE URINE TUBE DURING A VALIDATION, AN UNSPECIFIED NUMBER OF TUBES FAILED VALIDATION FOR 48 HOURS BASED ON MANUAL MICROBIOLOGY; THEY WERE ONLY ABLE TO VALIDATE FOR 24 HOURS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945825 ↗
• MalfunctionJun 6, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT ONE OF THE CAPS OF A BD VACUTAINER® C&S PRESERVATIVE URINE TUBE WAS MISSING, THUS AFFECTING STERILITY OF PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN ONE SHELF PACK THERE IS ONE TUBE WITHOUT CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604519 ↗
• MalfunctionDec 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® URINE TRANSFER STRAW HAD THE STOPPER POP OFF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TUBE IS POPPING OF STRAW".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13065000 ↗
• MalfunctionAug 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® C&S PRESERVATIVE URINE TUBE, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THIS EVENT OCCURRED TEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DR. REPORTED THAT DURING THE VALIDATION OF THE C&S TUBE (URINE - GRAY CAP) THEY WERE RECOVERING FEW MICROORGANISMS IN THE CULTURE MEDIUM. THE VALIDATION IS BEING CARRIED OUT AS FOLLOWING: SELECTION OF URINE SAMPLES WITHOUT MICROORGANISMS. REALIZATION OF BACTERIAL SUSPENSION (E. COLI ATCC 25922) IN 0.5MF SCALE AND SERIAL DILUTIONS UNTIL OBTAINING 50 CFU ON THE PLATE. INOCULATION OF THE BACTERIAL SUSPENSION IN THE C&S TUBE CONTAINING THE NEGATIVE URINE. INCUBATION OF THE C&S TUBE AND INOCULATION IN AGAR AT TIMES ZERO, 6H, 12H AND 24H. A SAMPLE INOCULATION FROM THE BLUE CAP PRIMARY TUBE IS ALSO PERFORMED. READING OF AGAR PLATES. IT WAS REPORTED THAT WHEN READING THE AGAR PLATES, THE QUANTIFICATION OF CFU WAS MUCH LOWER AFTER 12 HOURS OF INCUBATION IN THE C&S TUBE, CAUSING LITTLE RECOVERY OF MICROORGANISMS. DILUTIONS MUST BE PERFORMED ON URINE SAMPLES; MICROORGANISM TESTED: E. COLI FROM RECENT GROWTH IN CPS, PREPARE SUSPENSIONS WITH TURBIDITY EQUIVALENT TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358306 ↗
• MalfunctionJul 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® C&S PRESERVATIVE URINE TUBE, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: LOW RECOVERY OF MICROORGANISMS AFTER INCUBATION OF THE C&S TUBE FOR 12 HOURS. PHYSICIAN REPORTED THAT DURING THE VALIDATION OF THE C&S TUBE (URINE - GRAY CAP) THEY WERE MANAGING TO RECOVER FEW MICROORGANISMS IN THE CULTURE MEDIUM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12123300 ↗
• MalfunctionFeb 10, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THE BD VACUTAINER® C&S PRESERVATIVE URINE TUBE EXPERIENCED UNDERFILL OR LOW DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER STUDYING OUR RECOLLECTION DATA SINCE DECEMBER, OUR NUMBER OF RECOLLECTS FOR GRAY TOP URINE TUBES BEING UNDERFILLED HAS INCREASED (FROM 1-2 PER MONTH TO 10-15 PER MONTH). NO HARM OR INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11308469 ↗
• MalfunctionSep 9, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING USE FOREIGN MATTER "MOISTURE" WAS DISCOVERED IN TUBE WITH A BD VACUTAINER® C&S PRESERVATIVE URINE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NOTICED THAT THE INSIDE OF THE GREY TOP HAD A BIT OF MOISTURE WHICH CAUSED THE POWDER INSIDE TO CLUMP AND NOT BREAK DOWN ONCE FILLED WITH AN ACTUAL URINE SPECIMEN. I AM NOT AWARE OF ANY ERRONEOUS RESULTS BECAUSE THE TUBES WERE PULLED BEFORE WE COULD USE ANY.

  Patient problems: No Patient Involvement

  MAUDE report 10512136 ↗
• MalfunctionAug 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THE BD VACUTAINER® C&S PRESERVATIVE URINE TUBE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WAS TRANSLATED FROM SPANISH TO ENGLISH: THE CUSTOMER STATED ¿34-YEAR-OLD FEMALE PATIENT, GOES TO THE LABORATORY. SAMPLE IS RECEIVED VERIFYING COMPLIANCE WITH COLLECTION REQUIREMENTS (PRE-CLEANING, MEDIUM STREAM URINE, SAMPLE RECEPTION TIME LESS THAN 2 HOURS FROM COLLECTION, WITHOUT CONSUMPTION OR APPLICATION OF ANTIBIOTICS OR ANTISEPTICS). THE SAMPLE IS PROCESSED AND IT PROCEEDS TO SOW IN ENRICHMENT, SELECTIVE AND DIFFERENTIAL MEDIA. THE FOLLOWING URINARY SEDIMENT IS OBSERVED: EPITHELIAL CELLS: 48 CÉL / UL LEUKOCYTES: GREATER THAN 500 CÉL / UL ERYTHROCYTES: 82 CÉL / UL BACTERIA: RARE URINARY SEDIMENT IS CONFIRMED BY MEANS OF FLOW CYTOMETRY, CHECKING FOR THE PRESENCE OF BACTERIA AND WITH A PRELIMINARY RESULT OF PURE POPULATION OF GRAM NEGATIVE ON HISTOGRAMS. GRAM STAINING IS PERFORMED BY CHECKING THE REPORTED POPULATION BY CYTOMETRY. AFTER THE 24 HOUR INCUBATION PERIOD ENDED, NO DEVELOPMENT OF BACTERIAL COLONIES WAS OBSERVED; THE MODIFIED ENRICHMENT TECHNIQUE FOR BIOFILM-FORMING BACTERIA IS CARRIED OUT AND IT IS LEFT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10356655 ↗
• MalfunctionNov 12, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE BD VACUTAINER® C&S PRESERVATIVE URINE TUBE EXPERIENCED TUBE USE AFTER EXPIRATION DATE WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 364951; BATCH NO: UNKNOWN. IT WAS REPORTED THE TUBES WERE POST EXPIRATION. THE CUSTOMER IS INQUIRING ON IF THIS WILL AFFECT THE GROWTH OR OVER GROWTH. CUSTOMER DID NOT WANT TO MAKE THIS A COMPLAINT, CUSTOMER JUST WANTED INFORMATION ON THE RESULTS. NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9309564 ↗
• MalfunctionOct 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® C&S PRESERVATIVE URINE TUBES EXPERIENCED DISCOLORED/ABNORMAL ADDITIVE FORM WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 364951, BATCH NO. 9220404. PER EMAIL: WE JUST RECEIVED 3 CASES OF 364951 URINE C&S PRESERVATIVE. THE TUBES CAME WITH THE WHITE PRESERVATIVE IN LIQUID FORM INSTEAD OF POWDER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9240212 ↗
• MalfunctionMay 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED WITH A BD VACUTAINER® C&S PRESERVATIVE URINE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE ARE SIMPLY TRYING TO RULE OUT CONTAMINATION ISSUES BY ELIMINATING THE TUBES. THERE IS NO FOUNDATION FOR THE INQUIRY JUST SIMPLY ASKING IF ANYTHING HAS BEEN IDENTIFIED OR REPORTED TO BD, TO SIMPLY RULE THE TUBES OUT AS THE REASON FOR HIGH CONTAMINATION RATES. WE WERE A PART OF A STUDY IN THE PAST WHERE WE IDENTIFIED SOMETHING WITH THE PLATES WE WERE USING, BECAUSE OF THE RESULTS WE WERE SEEING, SO WE NOTIFIED THE VENDORS AND THEN FOUND OUT THERE WAS AN ISSUE WITH THE PLATES THAT WE WEREN¿T MADE AWARE OF. SO LET¿S SEE WHAT BD REPORTS MAYBE IT WILL BE NOTHING. BUT THAT WILL HELP US RULE THE TUBES OUT. AND THAT¿S REALLY ALL WE¿RE TRYING TO DO HERE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654971 ↗
• MalfunctionOct 23, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USE OF THE BD VACUTAINER C&S PRESERVATIVE URINE TUBE, THAT THERE WAS ERRONEOUS RESULTS. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7996222 ↗
• MalfunctionAug 20, 2018Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® C&S PRESERVATIVE URINE TUBE, THAT THEY ARE NOT FILLING PROPERLY WHEN PULLING FROM THE FOLEY CATHETER. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7798829 ↗
• MalfunctionJul 31, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® C&S PRESERVATIVE URINE TUBE THERE WAS AN ISSUE WITH LABELING ERROR. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7736567 ↗
• MalfunctionJun 14, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT THE BD VACUTAINER® C&S PRESERVATIVE URINE TUBE GAVE ERRONEOUS RESULTS. 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 7602999 ↗
• MalfunctionJun 12, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BD VACUTAINER® C&S PRESERVATIVE URINE TUBE WAS CRACKED. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7592124 ↗
• MalfunctionJun 12, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® C&S PRESERVATIVE URINE TUBE HAD LOW VACUUM. 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 7591918 ↗
• MalfunctionJun 8, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THE BD VACUTAINER® C&S PRESERVATIVE URINE TUBE HAD INCORRECTLY COLLECTED BLOOD ISSUE. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7584197 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K024240. One submission often covers many models, so check the product and lot details in each record.

• Z-1024-2010 · Oct 12, 2009 · Terminated
  BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens; Plus Plastic - Sterile Cup and Tube interiors. Store at 4-25 degrees C. Kit contai
• Z-1023-2010 · Oct 12, 2009 · Terminated
  BD Vacutainer Urine Cup Kit with C&S Preservative Tube for Midstream specimens; 50; Becton Dickinson and Company, Franklin Lakes, NJ 07417; Kit contains Sterile Screw-Cap collectio
• Z-1025-2010 · Oct 12, 2009 · Terminated
  BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for Midstream Specimens PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C.