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Sources: EU EUDAMED, US FDA
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Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain.
FDA Recall
Terminated
·Coloplast Manufacturing US, LLC·Product code EZL·March 22, 2016
Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Recall
Terminated
·Covidien LLC·Product code EZL·January 22, 2016
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020
Temperature sensing catheter 14FR, Catalogue Number 102201101463NU 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 simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018
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 bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018
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 simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018
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 and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018
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 and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020
Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Recall
Terminated
·Covidien LLC·Product code EZL·January 22, 2016
Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and female patients
FDA Recall
Terminated
·Covidien LLC·Product code EZL·January 22, 2016
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 bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
FDA Recall
Terminated
·Medline Industries Inc·Product code EZL·May 28, 2019
Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
FDA Recall
Terminated
·Covidien LLC·Product code EZL·January 22, 2016
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code EZL·July 11, 2016
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 and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018
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 urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018
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 from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018
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 bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018