Home › Device types › FCN
Urinary Drainage Collection Kit, For Indwelling Catheter
FDA product code FCN · Class 2 · Gastroenterology, Urology
79
Registered devices
87
Adverse events
3
Recalls
10
510(k) clearances
Devices with this code
Goldberg — COOK INCORPORATEDMEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC.Dover — Cardinal Health, Inc.SURGYCO — Surgyco LLCDover — Cardinal Health, Inc.ProCure — Twin Med, LLCCook — COOK INCORPORATEDCook — COOK INCORPORATEDCook — COOK INCORPORATEDDeRoyal — DEROYAL INDUSTRIES, INC.Closed System Foley Catheter Tray Pre-Connected Closed Circuit: 14 Fr — Dynarex CorporationDover — Cardinal Health 200, LLCMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.Dover — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCSteriGear — Sterigear, LLCTruCath — HR PHARMACEUTICALS INC.SteriGear — Sterigear, LLCSteriGear — Sterigear, LLCDover — Cardinal Health, Inc.MEDLINE — MEDLINE INDUSTRIES, INC.Dover — Cardinal Health 200, LLCDover — Cardinal Health, Inc.Dover — Cardinal Health, 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. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2011-01-11 | SteriGear, LLC | SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return v |
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