Catheter, Urological (antimicrobial) And Accessories
Gastroenterology, Urology · 21 CFR 876.5130
Recent MDR events
16,326 adverse event reports on file
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05056
- Bardex® Lubri-Sil® I.C. All-Silicone Foley CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05053
- Bardex® I.C. Foley CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05059
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05064
- Bardex® I.C. Foley CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05063
- Bardex® I.C. Foley CatheterJul 31, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05062
- Bardex® I.C. Foley CatheterJul 30, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05004
- Bardex® I.C. Temperature Sensing Foley CatheterJul 30, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-04998
- Bardex® I.C. Temperature Sensing Foley CatheterJul 30, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05002
- Bardex® I.C. Foley CatheterJul 30, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-05024
Event type breakdown
Most-reported manufacturers
Recalls
22 recall events for this product code
- C.R. Bard IncOpen, ClassifiedSep 18, 2025
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Z-2589-2025 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 18, 2025
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Z-2590-2025 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 18, 2025
SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Z-2591-2025 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedJun 18, 2024
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Cathet
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
Z-2154-2024 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
Z-2521-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
Z-2522-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
Z-2523-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
Z-2524-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
Z-2525-2021 · View FDA record ↗ - C.R. Bard IncOpen, ClassifiedSep 23, 2021
Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
Z-2526-2021 · View FDA record ↗
Registered firms
42 firms currently registered for this product code
Productos Para El Cuidado De La Salud
NOGALES Sonora, MX
C.r. Bard, Inc.
MADISON, GA, US
C.r. Bard, Inc.
COVINGTON, GA, US
Bard Sdn. Bhd.
KULIM Kedah, MY
Shipserve New Zealand Limited
Ellerslie Auckland, NZ
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Deroyal Industries, Inc.
POWELL, TN, US
Well Lead Medical (hainan) Co., Ltd.
Haikou Hainan, CN
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Isomedix Operations, Inc
ONTARIO, CA, US
510(k) clearances
10 clearances for this product code
- Well Lead Medical (Hainan) Co., Ltd.Jun 6, 2024
K233094 · Wellead® Latex Foley Catheter
- C.R. Bard, Inc.Sep 29, 2004
K040658 · BARDEX I.C. LATEX FOLEY CATHETER
- Rochester Medical Corp.Jun 10, 2004
K033477 · HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
- Cook Urological, Inc.Aug 30, 2000
K000251 · SPECTRUM SILICONE FOLEY CATHETER
- Rochester Medical Corp.Jul 7, 2000
K001143 · RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
- C.R. Bard, Inc.Dec 10, 1999
K993464 · BARDEX I.C. PEDIATRIC FOLEY CATHETER
- Bard Medical Div.Feb 16, 1999
K984136 · BARDEX LUBRI-SIL I.C. FOLEY CATHETER
- C.R. Bard, Inc.Nov 3, 1998
K983101 · BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24