Home › Device types › KNX
Collector, Urine, (And Accessories) For Indwelling Catheter
FDA product code KNX · Class 2 · Gastroenterology, Urology
482
Registered devices
2,118
Adverse events
19
Recalls
206
510(k) clearances
Devices with this code
Dover — Cardinal Health 200, LLCDover — Cardinal Health, Inc.Urocare® Leg Bag Holder, Lower Large — UROCARE PRODUCTS, INC.Bard® Center Entry Urine Meter Add-A-Foley Tray with Bard EZ-Lok® Sampling Port — C. R. Bard, Inc.Dover — Cardinal Health, Inc.Urine Bag — Well Lead Medical Co.,LtdDover — Cardinal Health 200, LLCAMSure® Urinary Drainage Bag — AMSINO INTERNATIONAL, INC.Dover — Cardinal Health, Inc.MEDLINE — MEDLINE INDUSTRIES, INC.Urine Bag — Well Lead Medical Co.,LtdUro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) — UROCARE PRODUCTS, INC.Medline — MEDLINE INDUSTRIES, INC.Bard® Urine Meter with Bag — C. R. Bard, Inc.Bard® Add-A-Foley Urine Meter Foley Tray — C. R. Bard, Inc.RUSCH — TELEFLEX INCORPORATEDDover — Cardinal Health 200, LLCGLOBAL HEALTHCARE — GHC HEALTHCARE, INC.Dover — Cardinal Health, Inc.Dover — Cardinal Health, Inc.Dover — Cardinal Health 200, LLCUrocare® Fabric Leg Strap Kit with Velcro® Fasteners, Small (Set of 2) — UROCARE PRODUCTS, INC.Urine Bag — Well Lead Medical Co.,LtdUrocare® Fabric Foley® Catheter/Tubing Strap Standard 18" — UROCARE PRODUCTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.