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

1–25 of 32

HighFDA (Devices)··2018-09-26
Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors
Degania Silicone is recalling Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP 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 blad
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 a
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 an
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors
Degania Silicone, Ltd. is recalling 1,588 Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI 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 and
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 actual.
Product
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD 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 fr
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 8FR, Catalogue Number 102201100880JP 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 bladd
Category
Distribution
3 states
ModerateFDA (Devices)··2018-09-26
Foley Catheter with Temperature Sensor Recalled for Defective Sensors
Degania Silicone is recalling 12,532 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY 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 u
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 2,461 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature sensing catheter 18FR, Catalogue Number 102203101863DO 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 a
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 an
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 34,627 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 102203101663DO 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 a
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Foley Catheters Recalled for Defective Temperature Sensors
Degania Silicone is recalling 500 units of temperature-sensing Foley catheters because defective sensors may display inaccurate, lower body temperature readings.
Product
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD 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 fr
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 330 Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD 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 Foley Catheters with Defective Temperature Sensors
Degania Silicone is recalling 4,332 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY 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 ur
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 11,488 temperature sensor Foley catheters because defective sensors may display lower body temperatures than actual.
Product
Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB 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 bladd
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD 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 bladd
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 500 units of temperature sensor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB 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 blad
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 500 sterile Foley catheters with defective temperature sensors that may display inaccurate readings.
Product
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD 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 fr
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Recalls Foley Catheters with Defective Temperature Sensors
Degania Silicone is recalling 89,122 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY 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 u
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 blad
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 4,372 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature sensing catheter 14FR, Catalogue Number 102203101463DO 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 a
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 100 units of temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.
Product
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD 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 fr
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Temperature Sensor Catheters Recalled for Defective Sensors
Degania Silicone is recalling 16,350 temperature sensor catheters because defective sensors may display lower body temperatures than actual.
Product
Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI 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 an
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 bladd
Category
Distribution
3 states
HighFDA (Devices)··2018-09-26
Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 1,025 Temperature Sensor Catheters because defective sensors may display lower body temperatures than actual patient readings.
Product
Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI 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 an
Category
Distribution
3 states
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 an
Category
Distribution
3 states