Home › Device types › FCM
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
FDA product code FCM · Class 2 · Gastroenterology, Urology
403
Registered devices
800
Adverse events
43
Recalls
60
510(k) clearances
Devices with this code
Dover — Cardinal Health, Inc.Self-Cath Closed System — Coloplast A/SGENTLECATH — CONVATEC, PURCHASING DEPARTMENTAMSure® Pre-Connected Urethral Tray — AMSINO INTERNATIONAL, INC.Dover — Cardinal Health, Inc.Apogee Plus — HOLLISTER INCORPORATEDSelf-Cath Closed System — Coloplast A/SDover — Cardinal Health, Inc.Advance Plus Pocket — HOLLISTER INCORPORATEDCure Catheter® Closed System — CONVATEC, PURCHASING DEPARTMENTNURSE ASSIST — NURSE ASSIST, INC.AMSure® Foley Insertion Tray — AMSINO INTERNATIONAL, INC.Self-Cath Closed System — Coloplast A/SCure Catheter® Closed System — CONVATEC, PURCHASING DEPARTMENTAdvance Plus Pocket — HOLLISTER INCORPORATEDSelf-Cath Closed System — Coloplast A/SAMSure® Foley Catheter Tray — AMSINO INTERNATIONAL, INC.Advance Plus Pocket — HOLLISTER INCORPORATEDBard® Touchless® Urethral Catheter Kit With Red Rubber Catheter — C. R. Bard, Inc.GENTLECATH — CONVATEC, PURCHASING DEPARTMENTAMSure® Foley Catheter Tray — AMSINO INTERNATIONAL, INC.Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Coude Urethral Catheter — C. R. Bard, Inc.AMSure® Foley Insertion Tray — AMSINO INTERNATIONAL, INC.Dover — Cardinal Health 200, LLC
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 |
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.