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SimPro™ Set
Wellspect AB · Model 5351000 · UDI-DI 07333387043791
10
510(k) clearances
4,229
Adverse events (6 deaths)
13
Recalls
85
Facilities
Description
Single Use Urinary Catheter with water sachet and Accessories. Coudé 16" 10FR
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.