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...
Reason: 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.
Z-2755-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. I...
Reason: 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.
Z-2769-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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 i...
Reason: 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.
Z-2758-2018September 26, 2018Dganya Bet, N/A
COVIDIEN LLC
Class IITerminated
P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS
Reason: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Z-3208-2018September 26, 2018Mansfield, MA
Degania Silicone, Ltd.
Class IITerminated
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 ...
Reason: 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.
Z-2782-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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...
Reason: 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.
Z-2768-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It...
Reason: 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.
Z-2777-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the thi...
Reason: 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.
Z-2764-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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...
Reason: 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.
Reason: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Z-3206-2018September 26, 2018Mansfield, MA
Degania Silicone, Ltd.
Class IITerminated
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 ...
Reason: 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.
Z-2785-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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 i...
Reason: 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.
Z-2762-2018September 26, 2018Dganya Bet, N/A
COVIDIEN LLC
Class IITerminated
TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T
Reason: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Z-3204-2018September 26, 2018Mansfield, MA
Degania Silicone, Ltd.
Class IITerminated
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. I...
Reason: 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.
Z-2770-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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 i...
Reason: 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.
Z-2760-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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. I...
Reason: 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.
Z-2771-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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 i...
Reason: 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.
Z-2761-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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 thi...
Reason: 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.
Z-2767-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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. I...
Reason: 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.
Z-2756-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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 i...
Reason: 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.
Z-2779-2018September 26, 2018Dganya Bet, N/A
Degania Silicone, Ltd.
Class IITerminated
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 thir...
Reason: 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.
Z-2763-2018September 26, 2018Dganya Bet, N/A
COVIDIEN LLC
Class IITerminated
P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS
Reason: The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Z-3207-2018September 26, 2018Mansfield, MA
Arrow International Inc
Class IITerminated
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
Reason: The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 ...
Z-3200-2018September 26, 2018Reading, PA
Degania Silicone, Ltd.
Class IITerminated
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...
Reason: 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.
Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life...