Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 947314Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741024924), received between Feb 25, 2025 and Feb 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING THE ACTIVITY, A NEW FOLEY TRAY WAS USED FOR THE DEMONSTRATION, BUT WHEN IT WAS OPENED FOR PRACTICAL USE, THE LACK OF THE SYRINGE PREFILLED WITH THE SOLUTION WAS DETECTED, ATTACHED THE DATA OF SAID TRAY. ADDITIONAL INFORMATION RECEIVED ON 10FEB2025, THAT IT WAS DURING A TRAINING, THE KIT WAS OPENED IN WHICH THE MISSING SYRINGE WAS DETECTED WITH STERILE WATER. THE PREFILLED SYRINGE WAS NOT AVAILABLE, THAT'S WHY IT WAS NOT POSSIBLE TO KNOW THE DETAIL OF THE MATERIAL AND BATCH SINCE IT WAS A COMPONENT OF THE KIT. THE DATE OF THE EVENT WAS (B)(6) 2025. PER FOLLOW UP INFORMATION RECEIVED ON 18FEB2025, THEY CONFIRMED THE INVOLVEMENT OF THE NURSING STAFF WHO WERE INVOLVED WHEN THIS EVENT OCCURRED, AS IT WAS DURING A TRAINING WITH NEW STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459284 ↗