FDA (Devices) recall action 80747
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
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.
Coviden is recalling temperature sensing Foley catheters because they may display lower body temperature readings than the patient's actual temperature.
COVIDIEN LLC is recalling P400 temperature sensor catheters because they may display lower body temperature measurements than the patient's actual temperature.
Coviden is recalling Temp Sense Silicone catheters because they may display lower body temperature measurements than the patient's actual temperature.
Coviden is recalling specific sterile Foley catheter trays because the temperature sensors may display lower body temperature readings than the patient's actual temperature.
Covidien is recalling P400 temperature sensor catheters because they may display lower body temperature readings than the patient's actual temperature.
Coviden is recalling temperature sensing Foley catheters that may display lower body temperature measurements than the patient's actual temperature.