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LoFric® Origo™
Wellspect AB · Model 44912 · UDI-DI 07333387053110
EZD
Prescription
10
510(k) clearances
4,229
Adverse events (6 deaths)
13
Recalls
85
Facilities
Description
Single Use Urinary Catheter with salt solution. LoFric Origo Sleeve Coudé FX Male 40cm FR12, Sterile device.
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 product packaging that co |
| 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 product packaging that co |
| 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 product packaging that co |
| 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 product packaging that co |
| 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 tip. |
| 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 tip. |
| 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 tip. |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.