SureStep™ Foley Tray System Bard® Lubricath® Foley Catheter Tray A800061Recalls & reported problems
C. R. Bard, Inc. · SureStep® Foley Tray System Bard Lubricath Foley Catheter Tray - 2000 ml Drainage Bag · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
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 00801741104848), received between Sep 18, 2023 and Sep 19, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Aug 5, 2021Class IIOpen, Classified
There is potential for packaging defects that may impact the sterile barrier.
Z-2529-2021 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A STERILE SYRINGE THAT WAS IN A FOLEY CATHETER KIT. FORTUNATELY, CUSTOMER NOTICED THE HAIR BEFORE USING THE SYRINGE ON A PATIENT'S STERILE PROCEDURE. THIS WAS NOT THE NURSE'S HAIR (THOUGHT THEY WOULD ADD THAT, THEY WERE DEFINITELY BLONDE). THE HAIR WAS LODGED IN THE CAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17772884 ↗MalfunctionSep 18, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE SYRINGE FROM THE SURESTEP FOLEY TRAY HAD HAIR ON THE CAP. FORTUNATELY, THEY NOTICED THE HAIR BEFORE USING THE SYRINGE ON A PATIENT'S STERILE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17763785 ↗
Other CATHETER, COUDE devices
- Bardex® Lubricath® Foley Catheter 0165L14C. R. Bard, Inc. · CATHETER, COUDE562 reports
- Bardex® Lubricath® Foley Catheter 0165L16C. R. Bard, Inc. · CATHETER, COUDE539 reports
- Bardia® Foley Catheter Silicone Coated 123516AC. R. Bard, Inc. · CATHETER, COUDE381 reports
- Bardia® Foley Catheter Silicone Coated 123514AC. R. Bard, Inc. · CATHETER, COUDE195 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A899916C. R. Bard, Inc. · CATHETER, COUDE3 recalls19 reports
- Bardia® Foley Catheter Silicone Coated 123518AC. R. Bard, Inc. · CATHETER, COUDE153 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A902916C. R. Bard, Inc. · CATHETER, COUDE2 recalls50 reports
- Bard® Lubricath® Foley Catheter 365716C. R. Bard, Inc. · CATHETER, COUDE117 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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