Catheter, Urological (antimicrobial) And Accessories
C.r. Bard, Inc.'s record for this product code
Recent MDR events
15,692 adverse event reports on file
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley CatheterJul 31, 2026Malfunction1018233-2026-05056
- Bardex® Lubri-Sil® I.C. All-Silicone Foley CatheterJul 31, 2026Malfunction1018233-2026-05053
- Bardex® I.C. Foley CatheterJul 31, 2026Malfunction1018233-2026-05059
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley CatheterJul 31, 2026Malfunction1018233-2026-05064
- Bardex® I.C. Foley CatheterJul 31, 2026Malfunction1018233-2026-05063
- Bardex® I.C. Foley CatheterJul 31, 2026Malfunction1018233-2026-05062
- Bardex® I.C. Foley CatheterJul 30, 2026Malfunction1018233-2026-05004
- Bardex® I.C. Temperature Sensing Foley CatheterJul 30, 2026Malfunction1018233-2026-04998
- Bardex® I.C. Temperature Sensing Foley CatheterJul 30, 2026Malfunction1018233-2026-05002
- Bardex® I.C. Foley CatheterJul 30, 2026Malfunction1018233-2026-05024
Recalls
20 recall events for this product code
- Open, ClassifiedSep 18, 2025
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
View FDA record ↗ - Open, ClassifiedSep 18, 2025
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
View FDA record ↗ - Open, ClassifiedSep 18, 2025
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
View FDA record ↗ - Open, ClassifiedJun 18, 2024
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
View FDA record ↗ - Open, ClassifiedSep 23, 2021
There is potential for packaging defects that may impact the sterile barrier.
View FDA record ↗ - Open, ClassifiedSep 23, 2021
There is potential for packaging defects that may impact the sterile barrier.
View FDA record ↗ - Open, ClassifiedSep 23, 2021
There is potential for packaging defects that may impact the sterile barrier.
View FDA record ↗ - Open, ClassifiedSep 23, 2021
There is potential for packaging defects that may impact the sterile barrier.
View FDA record ↗ - Open, ClassifiedSep 23, 2021
There is potential for packaging defects that may impact the sterile barrier.
View FDA record ↗ - Open, ClassifiedSep 23, 2021
There is potential for packaging defects that may impact the sterile barrier.
View FDA record ↗
510(k) clearances
4 clearances for this product code