Bardex® Lubricath® Foley Catheter Tray 899914Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741024801), received between Sep 18, 2017 and Sep 16, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT, GENITAL CLEANING BEGAN WITH A CLOSED-CIRCUIT 14FR BLADDER CATHETER, AND WHEN THE COVER WAS REMOVED, THE CATHETER WAS MISSING IN THE FOLEY TRAY. THIS OCCURRED DURING THE INTRAOPERATIVE PERIOD. 14FR FOLEY CATHETER WITH A SEPARATE COLLECTION BAG WAS REQUESTED FROM THE SUB-CENTRAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062386 ↗
• MalfunctionMay 7, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE INDIVIDUAL PACKAGING BAG OF TWO PIECES OF THE PRODUCT WERE NOT SEALED LIKE THE OTHERS IN THE FOLEY TRAY. SINCE THE PRODUCTS WERE SUPPOSED TO BE STERILIZED AND THE BAGS WERE OPEN, THE PRODUCTS CANNOT BE USED IN HOSPITAL/PATIENTS DUE TO THE RISK OF CLINICAL COMPLICATIONS AND WERE KEPT AT DISTRIBUTOR'S WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316104 ↗
• MalfunctionApr 2, 2022Illegible Information; Illegible Information

  IT WAS REPORTED THAT NURSE DISCOVERED THAT THE FOLEY CATHETER KIT WHICH WAS ABOUT TO USE ON A PATIENT WAS MADE OF LATEX. STATED THAT THE NURSE DID NOT USE THIS PRODUCT ON THE PATIENT, BUT NOTABLY THE PACKAGING DID NOT IDENTIFY THAT THIS PRODUCT CONTAINED LATEX UNTIL AFTER THE STERILE PACKAGING WAS OPENED AND ONLY THEN IT WAS LISTED IN SMALL PRINT ON A PAPER PRODUCT INSERT. GIVEN THE PREVALENCE OF SERIOUS LATEX ALLERGIES, THIS PRODUCT DID NOT FEEL SAFE TO USE IN THE HOSPITAL. AND THERE WAS ANOTHER PRODUCT THEY FOUND THAT APPEARED TO HAVE IDENTICAL PACKAGING BUT WAS MADE OF SILICONE INSTEAD. THE FOLEY CATHETER KIT SEEMED SAFE FOR HOSPITAL USE, WHEREAS THE BARD LUBRICATH FOLEY CATHETER TRAY KIT CONTAINS LATEX. THE VISUAL APPEARANCE OF THE LATEX PACKAGE AND THE LATEX FREE PACKAGE WERE VERY SIMILAR, AND IT WAS EASY TO NOT NOTICE THE DIFFERENCE. IT WOULD BE MUCH BETTER IF THE PACKAGING WAS A DIFFERENT COLOR OR HAD A MUCH MORE PROMINENT LATEX WARNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13992238 ↗
• InjuryOct 19, 2018Leak/Splash; Fracture; Leak/Splash

  IT WAS REPORTED THAT DURING URINE DRAINAGE, A FRACTURE WAS OBSERVED AT THE TUBING JUNCTION SEAL AND AT THE BASE OF THE COLLECTION BAG. THE PATIENT HAD A URINARY TRACT INFECTION AFTER THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6)2018 , THE PATIENT RECEIVED TREATMENT FOR THE URINARY TRACT INFECTION. THE TYPE OF MEDICATION IS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 7987041 ↗
• MalfunctionSep 18, 2017Leak/Splash

  IT WAS REPORTED THAT UPON OPENING THE FOLEY TRAY, THE BETADINE FROM THE SWAB STICKS LEAKED INTO THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873459 ↗