# K040504: Bardex, Lubri-Sil and Lubri-Sil IC All-Silicone Foley Catheters

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 14, 2004 after 77 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bardex® All-Silicone Foley Catheter: named in the summary without a submission number
- (no number) Lubri-Sil® All-Silicone Foley Catheter: named in the summary without a submission number
- (no number) Lubri-Sil® All-Silicone I.C. Foley Catheter: named in the summary without a submission number

## Recalls of this device
- Jun 25, 2026 · Class II · Z-3115-2026: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Aug 5, 2021 · Class II · Z-2540-2021: There is potential for packaging defects that may impact the sterile barrier.
- Aug 5, 2021 · Class II · Z-2541-2021: There is potential for packaging defects that may impact the sterile barrier.
- Aug 5, 2021 · Class II · Z-2537-2021: There is potential for packaging defects that may impact the sterile barrier.
- Aug 5, 2021 · Class II · Z-2539-2021: There is potential for packaging defects that may impact the sterile barrier.

## Indications for use
The Bardex®, Lubri-Sil® and Lubri-Sil® I.C. All-Silicone Foley Catheters are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.

Source page: https://510kreport.com/device/K040504
Methodology: https://510kreport.com/methodology