FDA (Devices) recall action 82307
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Teleflex Medical is recalling RuSCH One piece Male External Regular Catheters because the labels incorrectly state the devices are sterile, though they are not required to be.
Teleflex Medical is recalling RuSCH One piece Male External Medium Catheters because the labels incorrectly state the devices are sterile, though they are not required to be.