Home › Device types › EZD
Catheter, Straight
FDA product code EZD · Class 2 · Gastroenterology, Urology
1,055
Registered devices
4,229
Adverse events
13
Recalls
86
510(k) clearances
Devices with this code
HydroSil Go™ Intermittent Urinary Catheter — C. R. Bard, Inc.Self-Cath — Coloplast A/SHydroSil Go™ Intermittent Urinary Catheter — C. R. Bard, Inc.Wellead PVC Hydrophilic Urethral Catheter — Well Lead Medical Co.,LtdGentleCath Hydrophilic — Wellspect ABPVC Hydrophilic Urethral Catheter — Chengdu Daxan Innovative Medical Tech. Co., Ltd.SimPro™ Now — Wellspect ABWellead PVC Hydrophilic Urethral Catheter — Well Lead Medical Co.,LtdMagic3 Go Male Catheter with SureGrip — C. R. Bard, Inc.SimPro™ Core — Wellspect ABLoFric® Primo™ — Wellspect ABLoFric® Primo™ — Wellspect ABLoFric® Sense™ — Wellspect ABHalyard — OWENS & MINOR DISTRIBUTION, INC.LoFric® Origo™ — Wellspect ABLoFric® — Wellspect ABWellead Hydrophilic Intermittent Catheter — Well Lead Medical Co.,LtdLoFric® Primo™ — Wellspect ABSimPro™ Set — Wellspect ABLoFric® Hydro-Kit™ — Wellspect ABSureCath Set — Coloplast A/SSimPro™ Set — Wellspect ABSimPro™ Now — Wellspect ABLuja Coude — Coloplast A/S
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-20 | C.R. Bard Inc | Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the produ |
| 2023-04-20 | C.R. Bard Inc | Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the produ |
| 2023-04-20 | C.R. Bard Inc | Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the produ |
| 2023-04-20 | C.R. Bard Inc | Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the produ |
| 2020-06-17 | Wellspect HealthCare (Division of DENTSPLY IH AB) | Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheter s distal t |
| 2020-06-17 | Wellspect HealthCare (Division of DENTSPLY IH AB) | Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheters distal ti |
| 2020-06-17 | Wellspect HealthCare (Division of DENTSPLY IH AB) | Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheters distal ti |
| 2017-09-14 | C.R. Bard, Inc. | Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. |
| 2017-09-14 | C.R. Bard, Inc. | Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. |
| 2017-09-14 | C.R. Bard, Inc. | Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. |
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