Bardex® Lubricath® Foley Catheter Tray 899916Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741024818), received between Oct 16, 2019 and Dec 29, 2021 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (2 reports).

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

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 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3114-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE NURSES FELT THAT THEY WERE HAVING A DIFFICULT TIME IN TELLING WHEN THE URINE WAS DONE FLOWING IN THE STRAIGHT CATHETER KIT WITH THE BAG ATTACHED, COMPARED TO WHEN THE KIT HAD A SEPARATE COLLECTION CONTAINER. THEY CONFIRMED HAVING THIS PROBLEM, AND USUALLY THEY JUST MANIPULATE THE BAG BY LIFTING IT UP TO SEE IF IT WAS STILL DRIPPING OR NOT. NURSES REPORTED THAT WITH A 16FR TRAY CONTAINING A REGULAR FOLEY BAG WHEN THEY OPEN THE CORNERS OF THE STERILE FIELD, THE FIRST STERILE DRAPE NOT FENESTRATED WAS PLACED ABOVE THE GLOVES, SO THEY COULD NOT REMOVE IT STERILELY TO USE IT TO EXTEND THE STERILE FIELD. ADDITIONALLY, THERE WAS SIGNIFICANT CONCERN WITH THE SIZE OF THE STERILE FIELD AND NOT HAVING ROOM TO PULL OUT THE TRAY TO ACCESS THE BAG AND CATHETER AND ASEPTICALLY LAY THE CATHETER INTO THE LUBRICATING GEL. THEY WERE ONLY USING METER TRAYS, AND THEY HAD ALL SURESTEP TRAYS, SO THIS WAS A SMALLER SQUARE TRAY WITH A BAG THAT SEEMED A BIT DIFFERENT. THEY FELT IT TO BE HARDER TO MANIPULATE STERILELY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021, THE CUSTOMER REPORTED THAT THERE WASN'T AN ISSUE WITH THE PRODUCT DRAINING BUT JUST A CONCERN FROM NURSES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114566 ↗
• MalfunctionDec 20, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE NURSES FELT THEY THAT WERE HAVING DIFFICULT TIME IN TELLING WHEN THE URINE WAS DONE FLOWING IN THE STRAIGHT CATHETER KIT WITH THE BAG ATTACHED, COMPARED TO WHEN THE KIT HAD A SEPARATE COLLECTION CONTAINER. THEY CONFIRMED HAVING THIS PROBLEM AND USUALLY THEY JUST MANIPULATE THE BAG BY LIFTING IT UP TO SEE IF IT WAS STILL DRIPPING OR NOT. NURSES REPORTED THAT WITH 16FR TRAY CONTAINING A REGULAR FOLEY BAG WHEN THEY OPEN THE CORNERS OF THE STERILE FIELD, THE FIRST STERILE DRAPE NOT FENESTRATED WAS PLACED ABOVE THE GLOVES, SO THEY COULD NOT REMOVE IT STERILELY TO USE IT TO EXTEND THE STERILE FIELD. ADDITIONALLY, THERE WAS SIGNIFICANT CONCERN WITH THE SIZE OF THE STERILE FIELD AND NOT HAVING ROOM TO PULL OUT THE TRAY TO ACCESS THE BAG AND CATHETER AND ASEPTICALLY LAY THE CATHETER INTO THE LUBRICATING GEL. THEY WERE ONLY USING METER TRAYS AND THEY HAD ALL SURESTEP TRAYS, SO THIS WAS A SMALLER SQUARE TRAY WITH A BAG THAT SEEMED A BIT DIFFERENT. THEY FELT IT TO BE HARDER TO MANIPULATE STERILELY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08DEC2021, CUSTOMER REPORTED THAT THERE WASN¿T AN ISSUE WITH THE PRODUCT DRAINING BUT JUST A CONCERN FROM NURSES THAT THEY C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048987 ↗
• MalfunctionDec 10, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRIMARY PACKAGING OF THE FOLEY TRAY ARRIVED COMPLETELY OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981420 ↗
• InjuryNov 30, 2020Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE INDWELLING CATHETERS ON 4 VETERANS HAD TO BE CHANGED WITHIN TWO DAYS. ALTHOUGH THE INDWELLING CATHETERS WERE ABLE TO BE FLUSHED, THE CATHETERS WERE NOT DRAINING URINE. HENCE, THE VETERAN¿S BLADDER WAS SCANNED TO CHECK IF THERE WAS ANY URINE PRESENT IN THE BLADDER. THE BLADDER SCAN REVEALED 900 ML OF URINE WITH THE FOLEY IN PLACE. HENCE, THE CATHETER WAS CHANGED, AND THE FOLEY HAS ONCE AGAIN STOPPED DRAINING. IT WAS ALSO REPORTED THAT THE URINE WAS COMING OUT AROUND THE CATHETER. THE BALLOON OF THE CATHETER WAS ASSESSED, AND IT WAS CONFIRMED THAT THE CORRECT AMOUNT OF NORMAL SALINE WAS HELD WITHIN THE BALLOON. IT WAS FURTHER REPORTED THAT THERE WERE ISSUES WITH THE INDWELLING CATHETERS ON FOUR UNITS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Urinary Retention

  MAUDE report 10919276 ↗
• InjurySep 1, 2020Biocompatibility; Device Markings/Labelling Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WITH LATEX ALLERGY HAD CATHETER FROM FOLEY KIT USED AND DEVELOPED AN ALLERGIC REACTION. PACKAGING DOES NOT MAKE IT VERY EVIDENT THAT PRODUCT CONTAINS LATEX. FOLEY HAS AN ASTERISK WHICH WAS DEFINED IN VERY SMALL PRINT ON THE SIDE AS CONTAINING LATEX. ON THE PACKAGING OF THE DEVICE, THERE ARE TWO SMALL ASTERISKS NEXT TO THE CATHETER, BUT THE LEGEND FOR THE WHAT THAT MEANS IT IS IN SMALL PRINT ON THE SIDE OF THE PACKAGE. PATIENT CONDUCTED PHYSICIANS OFFICE POST-OPERATIVE DAY WITH 3 COMPLAINTS OF IRRITATION FROM CATHETER AND THINKING THE PATIENT MAY HAVE YEAST INFECTION. PATIENT SEEN BY MEDICAL DOCTOR IN THE OFFICE WHERE SWELLING AND ERYTHEMA ON BILATERAL LABIA MINOR AND MAJORA WAS NOTED. CATHETER WAS REMOVED AND PATIENT COMPLETED VOIDING TRIAL SUCCESSFULLY. PATIENT WAS PRESCRIBED TRIAMCINOLONE CREAM TO THE VULVA THREE TIMES IN A DAY. PACKAGING WAS NOT SAVED AT MEDICAL DOCTOR OFFICE. HOSPITAL WAS NOTIFIED 2 DAYS AFTER PATIENTS VISIT TO THE MEDICAL DOCTOR OFFICE. THE CONCERN WITH THIS EVENT WAS THAT THE PACKAGING DOESN'T MAKE IT VERY OBVIOUS THAT THE PRODUCT CONTAINS LATEX. EVEN THOUGH REGISTERED NURSE WAS AWARE OF PATIENTS ALLERGY, THEY WERE NOT AWARE T

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Irritation; Reaction; Skin Irritation; Swelling

  MAUDE report 10480163 ↗
• MalfunctionOct 16, 2019Inaccurate Flow Rate; Obstruction of Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE URINE WOULD NOT DRAIN OUT OF THE CATHETER AFTER PLACEMENT. THE CATHETER WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9199320 ↗