Skip to content

SureStep™ Foley Tray System with Bard® Lubri-Sil® Catheter A942208Recalls & reported problems

C. R. Bard, Inc. · SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray 350 ml Urine Meter · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741100550), received between Oct 31, 2018 and Sep 24, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 25, 2026Open, 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 · FDA record ↗

Most reported problems

Device problems

  • Fluid/Blood Leak1
  • Material Rupture1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2019Material Rupture

    WHILE PREPARING PT. FOR PROCEDURE AN 8FR FOLEY CATHETER (REF: A942208, LOT: NGDQ3696) WAS INSERTED. STERILE TECHNIQUE WAS MAINTAINED WHEN INSERTING THE FOLEY CATHETER. AFTER VERIFYING THE BALLOON PORT SIZE (5ML) THE CIRCULATOR INJECTED 5ML OF STERILE WATER INTO THE BALLOON PORT. IT WAS NOTED THERE WAS NO RESISTANCE AND AFTER VERIFYING PLACEMENT (URINE WAS EMPTYING INTO THE FOLEY CONTAINER) THE FOLEY CATHETER CAME ALL THE WAY OUT WITH BALLOON DEFLATED AND STERILE WATER COMING OUT OF THE BALLOON. THE FOLEY CATHETER AND STERILE FIELD WERE TAKEN DOWN AND THROWN OUT. A NEW 8 FR. FOLEY CATHETER WAS PLACED WITH NO COMPLICATIONS. PACKAGING WAS KEPT BY CIRCULATOR AND CLINICIAN WAS NOTIFIED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9109222 ↗
  • MalfunctionOct 31, 2018Fluid/Blood Leak

    AFTER A FOLEY WAS PLACED, NURSING NOTED LATER THAT NIGHT THAT THE CLEAR AIR PORT OF THE FOLEY WAS LEAKING. THE RED SEAL WAS THEN REMOVED AND NEW TUBING WAS ATTACHED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8023575 ↗

Other CATHETER, RETENTION TYPE, BALLOON devices

All CATHETER, RETENTION TYPE, BALLOON devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.