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 catheters distal tip.
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.
The agency’s own wording, quoted from the enforcement report.
Wellspect HealthCare is voluntarily recalling specific LoFric Origo urethral catheters due to 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 urinary catheters because of a potential defect in the distal tip.