Lubri-Sil® I.C. Complete Care® Temp-Sensing Foley Catheter Tray and Urine Meter 319516AMRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741024696), received between Feb 28, 2018 and Oct 7, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (3 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-3115-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT LUBRICANT SYRINGE IN FOLEY CATHETER TRAY WAS CRACKED OR BROKEN AND UNABLE TO BE USED AS INTENDED. PRODUCT WAS BEING USED FOR TRAINING OR ASSESSMENT AND NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382805 ↗
• MalfunctionJul 12, 2022Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT WHEN OPENED THE TEMPERATURE SENSING FOLEY CATHETER KIT THERE WAS NO STERILE WATER SYRINGE IN THE KIT FOR INFLATING THE BALLOON, INSTEAD 2 SYRINGES OF LUBRICATION PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986456 ↗
• MalfunctionSep 1, 2020Component Missing

  IT WAS REPORTED THAT THE ANTISEPTIC SWAB STICKS WAS MISSING FROM THE TEMPERATURE SENSING FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10479155 ↗
• MalfunctionDec 30, 2019Short Fill; Inflation Problem; Short Fill

  IT WAS REPORTED THAT THE TRAY KIT'S SYRINGE WAS EMPTY, AND DID NOT HAVE THE STERILE WATER TO INFLATE THE FOLEY BALLOON.

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

  MAUDE report 9530693 ↗
• MalfunctionOct 2, 2019Inaccurate Flow Rate; Obstruction of Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE TEMPERATURE PROBE FOLEY HAD ISSUES WITH DRAINING IN THE PAST WEEK. THE FOLEY WAS PLACED IN THE ED AND REMAINED IN THE ICU PATIENT. IT REQUIRED FLUSHING TO ALLOW THE URINE STREAM TO FLOW.

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

  MAUDE report 9145939 ↗
• MalfunctionOct 2, 2019Inaccurate Flow Rate; Infusion or Flow Problem; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE TEMPERATURE PROBE FOLEY HAD ISSUES WITH DRAINING IN THE PAST WEEK. THE FOLEY WAS PLACED IN THE OR AND REMAINED IN THE ICU PATIENT. IT REQUIRED FLUSHING TO ALLOW THE URINE STREAM TO FLOW.

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

  MAUDE report 9145934 ↗
• MalfunctionOct 1, 2019Inaccurate Flow Rate; Obstruction of Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE TEMPERATURE PROBE FOLEY HAD ISSUES WITH DRAINING IN THE PAST WEEK. THIS FOLEY WAS PLACED IN EITHER ED OR L&M.

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

  MAUDE report 9142601 ↗
• MalfunctionAug 28, 2019Fluid/Blood Leak; Gel Leak; Gel Leak

  IT WAS REPORTED THAT WHEN THE NURSE WAS PLACING THE CATHETER FROM THE TEMP SENSING FOLEY TRAY, IT WAS NOTED THAT THE SALINE SYRINGE WAS UNCAPPED AND ONLY 3/10 ML OF THE SALINE REMAINED IN THE SYRINGE.

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

  MAUDE report 8941978 ↗
• MalfunctionJun 20, 2018Detachment Of Device Component; Misassembled; Device Operates Differently Than Expected; Misassembled

  IT WAS REPORTED THAT THE CAP WAS OFF ON THE SYRINGE AND THE INITIAL GEL FLOW WAS BROWN RATHER THAN CLEAR. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7621465 ↗
• MalfunctionFeb 28, 2018Leak/Splash

  IT WAS REPORTED THAT THE ANTI-MICROBIAL CONTROL-FIT OUTLET DEVICE SEEMS TO BE TEARING FROM THE DRAIN BAG, CAUSING IT TO LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302713 ↗