Bard® Touchless® Plus Unisex Pre-Lubricated Rubber Urethral Catheter Kit 4A5042Recalls & reported problems
C. R. Bard, Inc. · Bard® Touchless® Plus Unisex Pre-Lubricated Urethral Catheter Kit, Rubber Urethral Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741030505), received between Mar 12, 2021 and Sep 22, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Biocompatibility” (1 report).
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Biocompatibility1
- Component Misassembled1
Patient problems
- Urinary Tract Infection2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE PATIENT LEFT MESSAGE IN PATIENT HUB, PATIENT HAD RUN INTO 27 CATHETERS THAT DID NOT HAVE LUBRICANT. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23110193 ↗InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT SAID THEY HAD BEEN USING THE BARD TOUCHLESS PLUS INTERMITTENT CATHETER. THEIR SON HAD GOTTEN A HANDFUL OF URINARY TRACT INFECTION, WHICH THEY ARE LOOKING FOR ANSWERS. COULD YOU TELL THEM DID THIS KIT HAD STERILE GLOVES WAS THE ACTUAL CATHETER STERILE. THIS LABEL ON THE OUTSIDE THAT SAYS CERTAIN THINGS ARE STERILE. CONFUSES THEM AS THEY NEED TO HAD THIS BE A PERFECT STERILE CATHETER. IF THE GLOVES ARE NOT STERILE, DID YOU HAD STERILE GLOVES. IT WAS UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH FEMALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Patient problems: Urinary Tract Infection
MAUDE report 22953565 ↗InjuryMar 12, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT INDICATED A URINARY TRACT INFECTION AND ALTHOUGH THERE WAS NO ALLEGATION AGAINST THE PRODUCT.
Patient problems: Urinary Tract Infection
MAUDE report 11473983 ↗
Other Tray, catheterization, sterile urethral, with or without catheter (kit) devices
- Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter Kit 4A5144C. R. Bard, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)170 reports
- Bard® Touchless® Plus Unisex Pre-Lubricated Rubber Urethral Catheter Kit 4A7044C. R. Bard, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)54 reports
- Dover 3450LFCardinal Health, Inc. · Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall3 reports
- Dover 3450Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall1 report
- Dover 3410Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 8887600784Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 8887600776Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1 recall0 reports
- Dover 3408Cardinal Health 200, LLC · Tray, catheterization, sterile urethral, with or without catheter (kit)1 recall0 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page