Home › Device types › KNX
Collector, Urine, (And Accessories) For Indwelling Catheter
FDA product code KNX · Class 2 · Gastroenterology, Urology
488
Registered devices
2,383
Adverse events
21
Recalls
206
510(k) clearances
Devices with this code
Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 8.5" — UROCARE PRODUCTS, INC.Urocare® Reusable Latex Leg Bag 26 oz. (800 mL.) — UROCARE PRODUCTS, INC.Bard® 350ml Urine Meter Foley Tray with Bard EZ-Lok™ Sampling Port — C. R. Bard, Inc.Bardia® Foley Catheter Insertion Tray for 5cc Balloon — C. R. Bard, Inc.Dover — Cardinal Health 200, LLCUrocare® Fabric Leg Strap with Velcro® Fasteners, Sport sml/MED 15" to 24" DIA — UROCARE PRODUCTS, INC.Bard® Urine Meter for Ureteral Catheters — C. R. Bard, Inc.Medline — MEDLINE INDUSTRIES, INC.Bard® Urinary Drainage Bag — C. R. Bard, Inc.Urine Bag — Well Lead Medical Co.,LtdAMSure® Urinary Drainage Bag — AMSINO INTERNATIONAL, INC.Bard® Urinary Drainage Bag — C. R. Bard, Inc.Bard® Wide Leg Bag Straps — C. R. Bard, Inc.Urine Bag — Well Lead Medical Co.,LtdDover — Cardinal Health, Inc.Bard® Foley Catheterization Tray Uro-Prep™ Tray — C. R. Bard, Inc.Urine Bag — Well Lead Medical Co.,LtdBard® Flip-Flo™ Catheter Valve — C. R. Bard, Inc.Urine Bag — Well Lead Medical Co.,LtdDover — Cardinal Health, Inc.Dover — Cardinal Health, Inc.Dover — Cardinal Health 200, LLCBard® Urine Meter with Bag — C. R. Bard, Inc.CARDINAL HEALTH — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-25 | C.R. Bard Inc | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| 2026-06-25 | C.R. Bard Inc | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2019-01-14 | Teleflex Medical | The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device |
| 2019-01-14 | Teleflex Medical | The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. |
| 2017-06-02 | C.R. Bard, Inc. | Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier. |
| 2016-07-11 | C.R. Bard, Inc. | The product contained a latex catheter instead of a silicone catheter. |
| 2016-06-29 | C.R. Bard, Inc. | Labeling problem |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
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