BD Vacutainer® C&S Transfer Straw Kit 364953Recalls & reported problems
Becton, Dickinson And Company · KIT URIN TRANSTR 13X75 4.0 C&S GR · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Vacutainer C&S transfer straw kit is a urine transport kit. Many of the 126 reports describe leaks, product quality problems, or unsterile kits. The reports include no deaths and no injuries. Reports fell to 7 in the last 12 months from 17 in the previous 12. There is 1 open recall, from May 2022, over high temperatures before delivery.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 128
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 30382903649533), received between Oct 17, 2017 and Sep 16, 2026 — classified as 128 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (25 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Product Quality Problem25
- Incorrect, Inadequate or Imprecise Result or Readings24
- Leak/Splash21
- Delivered as Unsterile Product12
- Separation Problem6
- Device Contamination with Chemical or Other Material5
- Device Markings/Labelling Problem5
- Break4
Patient problems
- No Known Impact Or Consequence To Patient56
- No Clinical Signs, Symptoms or Conditions55
- Needle Stick/Puncture6
- No Consequences Or Impact To Patient6
- No Patient Involvement3
- No Information2
- Exposure to Body Fluids1
Recent adverse event reports
The 25 most recent of 128 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794653 ↗MalfunctionSep 9, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698899 ↗MalfunctionJan 28, 2026Break
IT WAS REPORTED WHILE USING BD VACUTAINER® C&S TRANSFER STRAW KIT, URINE COLLECTION STRAW KITS ARE BREAKING AT THE CONNECTION POINT TO THE ADAPTER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203746 ↗MalfunctionDec 19, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED WHILE USING BD VACUTAINER® C&S TRANSFER STRAW KIT, ONE (1) KIT HAD THE NEEDLE INSIDE THE KIT SEPARATED FROM THE STRAW. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23848746 ↗MalfunctionDec 18, 2025Short Fill; Short Fill
IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® C&S TRANSFER STRAW KIT, (25) TUBES DISPLAYED NOT ENOUGH VACUUM TO PULL URINE INTO THE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838602 ↗MalfunctionDec 12, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PRIOR TO THE USE OF THE BD VACUTAINER® C&S TRANSFER STRAW KITS, AN UNSPECIFIED NUMBER OF KITS WERE DISCOVERED TO HAVE HOLES IN THE PLASTIC BAGS CAUSING THE PRODUCT TO FALL OUT AND RUINS THE STERILITY. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789055 ↗MalfunctionDec 11, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED PRIOR TO USING THE BD VACUTAINER® C&S TRANSFER STRAW KITS, AN UNSPECIFIED NUMBER OF KITS HAD HOLES IN THE PLASTIC BAGS CAUSING THE PRODUCT TO FALL OUT AND COMPROMISE THE STERILITY. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23783959 ↗MalfunctionDec 10, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF KITS HAD THE NEEDLE INSIDE THE KIT SEPARATED FROM THE STRAW. ADDITIONALLY, THERE WERE REPORTS OF TUBES RECEIVED IN OPEN BAGS, AND SOME WERE MISSING A TUBE AND/OR A STRAW. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772224 ↗MalfunctionDec 9, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT PRIOR TO USE THE BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF KITS HAD THE NEEDLE INSIDE THE KIT SEPARATED FROM THE STRAW. ADDITIONALLY, THERE WERE REPORTS OF TUBES RECEIVED IN OPEN BAGS, AND SOME WERE MISSING A TUBE AND/OR A STRAW. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23762856 ↗MalfunctionAug 14, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF STOPPERS GET STUCK IN THE URINE TRANSFER STRAW HOLDER AND CAUSE SAMPLE LEAKAGE. SHORT VOLUME SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22811874 ↗MalfunctionAug 14, 2025Leak/Splash; Leak/Splash
REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF STOPPERS GET STUCK IN THE URINE TRANSFER STRAW HOLDER AND CAUSE SAMPLE LEAKAGE. SHORT VOLUME SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806188 ↗MalfunctionAug 14, 2025Leak/Splash; Leak/Splash
REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF STOPPERS GET STUCK IN THE URINE TRANSFER STRAW HOLDER AND CAUSE SAMPLE LEAKAGE. SHORT VOLUME SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806013 ↗MalfunctionJun 19, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF KITS HAD THE NEEDLE INSIDE THE STRAW SEPARATED FROM THE STRAW, INCLUDING: STRAWS DETACHING EXPOSING NEEDLES, EXTRA STRAWS WITH NEEDLES EXPOSED IN THE PACKAGE, AND NO STRAW AT ALL IN PACKAGE BUT HOLDER AND TUBE. ADDITIONALLY, THERE WERE REPORTS OF TUBES NOT FILLING, BENT/CRIMPED STRAWS, EMPTY PACKAGES, BROKEN PLASTIC AND POWDER INSIDE PACKAGE, AND A DOUBLE LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293141 ↗MalfunctionJun 19, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF KITS HAD THE NEEDLE INSIDE THE STRAW SEPARATED FROM THE STRAW, INCLUDING: STRAWS DETACHING EXPOSING NEEDLES, EXTRA STRAWS WITH NEEDLES EXPOSED IN THE PACKAGE, AND NO STRAW AT ALL IN PACKAGE BUT HOLDER AND TUBE. ADDITIONALLY, THERE WERE REPORTS OF TUBES NOT FILLING, BENT/CRIMPED STRAWS, EMPTY PACKAGES, BROKEN PLASTIC AND POWDER INSIDE PACKAGE, AND A DOUBLE LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293002 ↗MalfunctionJun 19, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF KITS HAD THE NEEDLE INSIDE THE STRAW SEPARATED FROM THE STRAW, INCLUDING: STRAWS DETACHING EXPOSING NEEDLES, EXTRA STRAWS WITH NEEDLES EXPOSED IN THE PACKAGE, AND NO STRAW AT ALL IN PACKAGE BUT HOLDER AND TUBE. ADDITIONALLY, THERE WERE REPORTS OF TUBES NOT FILLING, BENT/CRIMPED STRAWS, EMPTY PACKAGES, BROKEN PLASTIC AND POWDER INSIDE PACKAGE, AND A DOUBLE LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292985 ↗MalfunctionJun 19, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF KITS HAD THE NEEDLE INSIDE THE STRAW SEPARATED FROM THE STRAW, INCLUDING: STRAWS DETACHING EXPOSING NEEDLES, EXTRA STRAWS WITH NEEDLES EXPOSED IN THE PACKAGE, AND NO STRAW AT ALL IN PACKAGE BUT HOLDER AND TUBE. ADDITIONALLY, THERE WERE REPORTS OF TUBES NOT FILLING, BENT/CRIMPED STRAWS, EMPTY PACKAGES, BROKEN PLASTIC AND POWDER INSIDE PACKAGE, AND A DOUBLE LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292973 ↗MalfunctionJun 3, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT, 1 KIT CONTAINED AN EXTRA STRAW. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22136676 ↗MalfunctionJun 3, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT, 2 KITS WERE MISSING STRAWS COVERING THE NEEDLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22136675 ↗MalfunctionJun 3, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT, 1 KIT WAS MISSING THE STRAW COVERING THE NEEDLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135076 ↗MalfunctionMar 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED FOR BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF KITS HAD DEFECTIVE STRAWS THAT SEPARATED FROM THE NEEDLE. ONE CLEAN NEEDLE STICK WAS REPORTED; NO TREATMENT WAS NEEDED. IT WAS UNCLEAR IF ALL REPORTED INCIDENTS WERE BEFORE USE. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21653522 ↗MalfunctionMar 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD VACUTAINER® C&S TRANSFER STRAW KIT, 1 NEEDLE SEPARATED FROM THE STRAW WHILE ALIQUOTING A SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21644227 ↗MalfunctionMar 7, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED DURING USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT; AN UNSPECIFIED NUMBER OF STOPPERS ARE BEING PULLED OUT OF TUBE AFTER REMOVING STRAW. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21549191 ↗MalfunctionFeb 5, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF KITS HAD AN EXTRA STRAW IN THE PACKAGING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313219 ↗MalfunctionJan 21, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED FOR BD VACUTAINER® C&S TRANSFER STRAW KIT, THE STRAW WAS BROKEN AND EXPOSED THE NEEDLE IN AN UNSPECIFIED NUMBER OF KITS. IT WAS NOT PROVIDED IF THIS WAS FOUND PRIOR OR DURING USE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200817 ↗MalfunctionJan 14, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® C&S TRANSFER STRAW KIT, AN UNSPECIFIED NUMBER OF KITS HAD AN EXTRA UNCOVERED NEEDLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21151412 ↗
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 · TerminatedBD 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-1025-2010 · Oct 12, 2009 · TerminatedBD 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.
- Z-1023-2010 · Oct 12, 2009 · TerminatedBD 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
Other CULTURE MEDIA, NON-PROPAGATING TRANSPORT devices
- BD Vacutainer® C&S Preservative Urine Tube 364951Becton, Dickinson And Company · CULTURE MEDIA, NON-PROPAGATING TRANSPORT1 recall36 reports
- N/A R99Hardy Diagnostics · Culture Media, Non-Propagating Transport1 recall0 reports
- Transystem™ 900-0370Copan Italia SPA · Culture Media, Non-Propagating Transport1 recall0 reports
- BD Vacutainer® Boric Acid Sodium Borate/Formate C&S Urine Tube 364958Becton, Dickinson And Company · CULTURE MEDIA, NON-PROPAGATING TRANSPORT39 reports
- BD Vacutainer® Urine Complete Cup Kit 364956Becton, Dickinson And Company · CULTURE MEDIA, NON-PROPAGATING TRANSPORT38 reports
- BD™ Universal Viral Transport Flock Mini 220529Becton, Dickinson And Company · CULTURE MEDIA, NON-PROPAGATING TRANSPORT9 reports
- BD™ Universal Viral Transport Flock Flex Mini 220531Becton, Dickinson And Company · CULTURE MEDIA, NON-PROPAGATING TRANSPORT6 reports
- BD™ Universal Viral Transport for Viral, Specimens 220220Becton, Dickinson And Company · CULTURE MEDIA, NON-PROPAGATING TRANSPORT3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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