The Recall Desk

FDA (Devices) recall action 80641

Degania Silicone, Ltd. recalled 32 products on 2018-09-26

The FDA (Devices) publishes a recall like this one as 32 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 32 pages.

Products
32
Announced
2018-09-26
Critical
0
Units
367,531

Why these products were recalled

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a 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.

States named across these recalls

26–32 of 32

  • HighFDA (Devices)··2018-09-26

    Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors

    Degania Silicone is recalling 1,028 temperature sensor catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 475 Temperature Sensor Foley Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2018-09-26

    Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors

    Degania Silicone is recalling 250 Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 14,326 Thermistor Foley catheters because defective sensors may display inaccurate, lower body temperature readings.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2018-09-26

    Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors

    Degania Silicone is recalling 16,133 temperature sensor catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2018-09-26

    Degania Foley Catheters Recalled Due to Defective Temperature Sensors

    Degania Silicone is recalling Foley catheters with temperature sensors because defective units may display lower body temperatures than actual.

    Product
    Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the…
    Category
    Distribution
    3 states