Home › Device types › FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
FDA product code FCM · Class 2 · Gastroenterology, Urology
410
Registered devices
804
Adverse events
43
Recalls
60
510(k) clearances
Devices with this code
Cure Catheter® Closed System — CONVATEC, PURCHASING DEPARTMENTSelf-Cath Closed System — Coloplast A/SAdvance Plus — HOLLISTER INCORPORATEDCure Catheter® Closed System — CONVATEC, PURCHASING DEPARTMENTDover — Cardinal Health, Inc.Dover — Cardinal Health, Inc.Dover — Cardinal Health, Inc.Advance Plus Pocket — HOLLISTER INCORPORATEDDover — Cardinal Health, Inc.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Cure Catheter® Closed System — CONVATEC, PURCHASING DEPARTMENTAMSure® Urethral Catheterization Tray — AMSINO INTERNATIONAL, INC.Dover — Cardinal Health, Inc.Dover — Cardinal Health, Inc.Cure Catheter® Closed System — CONVATEC, PURCHASING DEPARTMENTNURSE ASSIST — NURSE ASSIST, INC.GENTLECATH — CONVATEC, PURCHASING DEPARTMENTApogee Plus — HOLLISTER INCORPORATEDAMSure® Foley Catheter Tray — AMSINO INTERNATIONAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.AMSure® Urethral Self Catheterization Kit 16Fr. — AMSINO INTERNATIONAL, INC.GENTLECATH — CONVATEC, PURCHASING DEPARTMENTAMSure® Preconnected Urethral Tray — AMSINO INTERNATIONAL, INC.Dover — Cardinal Health, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2022-11-01 | Cardinal Health | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a |
| 2022-11-01 | Cardinal Health | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a |
| 2022-11-01 | Cardinal Health | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a |
| 2022-11-01 | Cardinal Health | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a |
| 2022-11-01 | Cardinal Health | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a |
| 2022-11-01 | Cardinal Health | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a |
| 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 |
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