FDA (Devices) recall action 85905
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
The agency’s own wording, quoted from the enforcement report.
Wellspect HealthCare is voluntarily recalling specific LoFric Origo urinary catheters because of a potential defect in the distal tip.
Wellspect HealthCare is voluntarily recalling LoFric Origo urinary catheters due to a potential defect in the distal tip.
Wellspect HealthCare is voluntarily recalling specific LoFric Origo urethral catheters due to a potential defect in the distal tip.