SureStep™ Foley Tray System Bardex® IC Complete Care®
SureStep® Foley Tray System Bardex® IC Complete Care® Infection Control Temperature Sensing Foley Catheter Tray 350 ml Urine Meter
1manufacturer
22catalogue numbers in this listing
4510(k) clearances naming this product code
23recalls on this code
Who Else Makes It
Registered in Hainan.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical (Hainan) Co., Ltd. | Haikou | Hainan | Contract manufacturer | 3 |
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | MJC |
| Device type | Catheter, Urological (Antimicrobial) And Accessories |
| 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 | 2015-12-06 |
| Record revised | 2024-04-29 (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 | 2022-05-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A300316A | Catheter Gauge 16 Fr | In distribution |
| A304714A | Catheter Gauge 14 Fr | In distribution |
| A903314A | Catheter Gauge 14 Fr | In distribution |
| A300318A | Catheter Gauge 18 Fr | In distribution |
| A303314A | Catheter Gauge 14 Fr | In distribution |
| A319414A | Catheter Gauge 14 Fr | In distribution |
| A300314A | Catheter Gauge 14 Fr | In distribution |
| A304718A | Catheter Gauge 18 Fr | In distribution |
| A903318A | Catheter Gauge 18 Fr | In distribution |
| A304416A | Catheter Gauge 16 Fr | In distribution |
| A303318A | Catheter Gauge 18 Fr | In distribution |
| A304716A | Catheter Gauge 16 Fr | In distribution |
| A919416AM | Catheter Gauge 16 Fr | In distribution |
| A903316A | Catheter Gauge 16 Fr | In distribution |
| A303316A | Catheter Gauge 16 Fr | In distribution |
| A319418A | Catheter Gauge 18 Fr | In distribution |
| A319416A | Catheter Gauge 16 Fr | In distribution |
| A900314A | Catheter Gauge 14 Fr | Withdrawn |
| A900318A | Catheter Gauge 18 Fr | Withdrawn |
| A919418AM | Catheter Gauge 18 Fr | Withdrawn |
| A919414AM | Catheter Gauge 14 Fr | Withdrawn |
| A900316A | Catheter Gauge 16 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latex Foley Catheter | Well Lead Medical Co., Ltd. | 212 |
| Bardex® I.C. Foley Catheter | C.R. Bard, Inc. | 43 |
| Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley Tray | C.R. Bard, Inc. | 23 |
| Magic3™ Intermittent Catheter | C.R. Bard, Inc. | 20 |
| Lubri-Sil® I.C. Complete Care® Temperature-Sensing Urine Meter Foley Tray | C.R. Bard, Inc. | 20 |
| Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter | C.R. Bard, Inc. | 19 |
| Personal Catheter™ Intermittent Catheter | C.R. Bard, Inc. | 16 |
| Bardex® I.C. Complete Care® Foley Tray | C.R. Bard, Inc. | 16 |
| Magic3 Touchless™ Hydrophilic Intermittent Catheter System | C.R. Bard, Inc. | 15 |
| SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® | C.R. Bard, Inc. | 14 |
| SureStep™ Foley Tray System Bardex® I.C. Complete Care® Foley Catheter | C.R. Bard, Inc. | 13 |
| Bardex® I.C. Tiemann Model Coude Tip Foley Catheter | C.R. Bard, Inc. | 13 |
Showing 12 of 44. All products under Catheter, Urological (Antimicrobial) And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K040658 | 2004-09-29 |
| K993464 | 1999-12-10 |
| K983101 | 1998-11-03 |
| K910318 | 1994-08-18 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| 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. | 1760 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. | 11,780 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. | 350 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. | 11,600 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. | 420 units | |
| C.R. Bard, Inc. | UDI-DI | 2020-04-15 | Class II | Under Investigation by firm | There is potential for a white paper-type residue attached to the catheter. | 8392 units | 2021-05-20 |
Recalls
14 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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. | 212580 | |
| 2025-07-17 | Class II | Labeling mix-ups | 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 wit | 3670 | |
| 2025-07-17 | Class II | Labeling mix-ups | 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 wit | 4,300 | |
| 2025-07-17 | Class II | Labeling mix-ups | 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 wit | 4,300 | |
| 2024-05-09 | Class II | Component design/selection | Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices. | 6,420 devices | |
| 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 10,150 units | |
| 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 8170 units | |
| 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 5950 units | |
| 2018-12-13 | Class II | Device Design | potential for urine leakage around the vent on the vented sample port | 883,171 units | 2020-11-02 |
| 2018-12-06 | Class II | Device Design | Some SureStep” Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port. | 450 units | |
| 2017-07-28 | Class II | Employee error | Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating. | 45,270 units | 2020-08-25 |
| 2016-10-05 | Class II | Mixed-up of materials/components | Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating). | 10,290 units | 2021-10-08 |
| 2015-12-18 | Class II | Error in labeling | Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | 1,428,000 units (total) | 2016-06-29 |
| 2015-12-18 | Class II | Error in labeling | Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | 1,428,000 units (total) | 2016-06-29 |
| 2015-12-18 | Class II | Error in labeling | Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | 1,428,000 units (total) | 2016-06-29 |
| 2015-10-02 | Class III | Error in labeling | Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French. | 4,170 each | 2016-08-01 |
| 2002-08-29 | Not classified | Other | On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports. | 1461 units | 2003-09-19 |
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.