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Catheter, Urological
FDA product code KOD · Class 2 · Gastroenterology, Urology
1,831
Registered devices
17,035
Adverse events
107
Recalls
238
510(k) clearances
Devices with this code
Bard® Util-Cath™ Urethral Catheter — C. R. Bard, Inc.MTG EZ-Advancer® Soft — MEDICAL TECHNOLOGIES OF GEORGIA, INC.Level 1 — ICU MEDICAL, INC.Bardex® Lubricath® Foley Catheter — C. R. Bard, Inc.RUSCH — TELEFLEX INCORPORATEDUreteral Catheter — Well Lead Medical Co.,LtdAdvance Plus — HOLLISTER INCORPORATEDPersonal Catheter™ Intermittent Catheter — C. R. Bard, Inc.Bardex® Lubricath® Foley Catheter Hotter Model — C. R. Bard, Inc.RUSCH — TELEFLEX INCORPORATEDRUSCH — TELEFLEX INCORPORATEDBard® Rubber Utility Catheter — C. R. Bard, Inc.RUSCH — TELEFLEX INCORPORATEDDover — Cardinal Health 200, LLCDover — Cardinal Health 200, LLCRUSCH — TELEFLEX INCORPORATEDBardex® Lubricath® Foley Catheter — C. R. Bard, Inc.RUSCH — TELEFLEX INCORPORATEDGLIDEWIRE — TERUMO CORPORATIONDover — Cardinal Health 200, LLCRUSCH — TELEFLEX INCORPORATEDKoyle — COOK INCORPORATEDGENTLECATH — CONVATEC, PURCHASING DEPARTMENTAngled Tip — COOK INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-03 | C.R. Bard Inc | Cather packaging may contain the incorrect French size. |
| 2025-06-03 | C.R. Bard Inc | Cather packaging may contain the incorrect French size. |
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2022-09-20 | TELEFLEX LLC | Product may not be sterile |
| 2022-01-27 | C.R. Bard Inc | There is a potential to leak from the catheter where it connects to the drain bag |
| 2022-01-27 | C.R. Bard Inc | There is a potential to leak from the catheter where it connects to the drain bag |
| 2021-01-11 | C.R. Bard, Inc. | The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. |
| 2020-04-30 | Covidien Llc | Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body tem |
| 2020-04-30 | Covidien Llc | Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body tem |
| 2020-04-30 | Covidien Llc | Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body tem |
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