SureStep™ Foley Tray System Bard® Lubricath® Foley Catheter Tray
SureStep® Foley Tray System Bard® Lubricath® Foley Catheter Tray & 2000 ml Drainage Bag
1manufacturer
18catalogue numbers in this listing
4510(k) clearances naming this product code
11recalls on this code
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | EZC |
| Device type | Catheter, Coude |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-12-08 |
| Record revised | 2022-05-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
| Sizes | Catheter gauge 14 to 18 Fr |
| Distribution end date | 2022-05-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A800061 | Catheter Gauge 16 Fr | In distribution |
| A800364 | Catheter Gauge 14 Fr | In distribution |
| A902614 | Catheter Gauge 14 Fr | In distribution |
| A800064 | Catheter Gauge 14 Fr | In distribution |
| A800361 | Catheter Gauge 16 Fr | In distribution |
| A902618 | Catheter Gauge 18 Fr | In distribution |
| A899616 | Catheter Gauge 16 Fr | In distribution |
| A800065 | Catheter Gauge 16 Fr | In distribution |
| A800060 | Catheter Gauge 14 Fr | In distribution |
| A800366 | Catheter Gauge 18 Fr | In distribution |
| A800362 | Catheter Gauge 18 Fr | In distribution |
| A800365 | Catheter Gauge 16 Fr | In distribution |
| A800360 | Catheter Gauge 14 Fr | In distribution |
| A902616 | Catheter Gauge 16 Fr | In distribution |
| A800062 | Catheter Gauge 18 Fr | Withdrawn |
| A899618 | Catheter Gauge 18 Fr | Withdrawn |
| A800066 | Catheter Gauge 18 Fr | Withdrawn |
| A899614 | Catheter Gauge 14 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 26 |
| Rusch | Teleflex Medical LLC | 14 |
| SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 12 |
| Bard® Urine Meter Foley Tray with Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 11 |
| Bardex® Silicone Coated Foley Catheter | C.R. Bard, Inc. | 10 |
| Bardia | C.R. Bard, Inc. | 10 |
| Bardia® Foley Catheter Silicone Coated | C.R. Bard, Inc. | 10 |
| Bard® Foley Catheter Silicone Coated | C.R. Bard, Inc. | 10 |
| Bard® Lubricath® Foley Catheter | C.R. Bard, Inc. | 10 |
| Bardex® Silicone Elastomer-Coated Foley Catheter Kit | C.R. Bard, Inc. | 8 |
| Bardex® Lubricath® Hydrogel-Coated Foley Catheter Kit | C.R. Bard, Inc. | 8 |
| Bard® Foley Tray with Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 8 |
Showing 12 of 66. All products under Catheter, Coude
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K913341 | 1992-01-27 |
| K910846 | 1991-08-16 |
| K910197 | 1991-08-09 |
| K910195 | 1991-08-09 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| C.R. Bard, Inc. | UDI-DI | 2026-06-25 | Not classified | Under Investigation by firm | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. | 12,463 trays/kits |
| C.R. Bard, Inc. | UDI-DI | 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 2660 units |
| C.R. Bard, Inc. | UDI-DI | 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 1140 units |
| C.R. Bard, Inc. | UDI-DI | 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 33,380 units |
| C.R. Bard, Inc. | UDI-DI | 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 18,060 units |
| C.R. Bard, Inc. | UDI-DI | 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 80 units |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-06-03 | Class II | Under Investigation by firm | Cather packaging may contain the incorrect French size. | 63 units | |
| 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 960 units | |
| 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 29,890 units | |
| 2017-12-13 | Class II | Process control | Foley Catheter with Incorrect Retainer Cap Print | 2020-12-14 | |
| 2012-06-29 | Class II | Process control | Incomplete seal on sterile packages of product. | 56,694 units | 2013-02-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.