Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Brand
Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India
Lot Codes / Batch Numbers
Lot Numbers: S18013318 S18010936 S19006220 S19006221 S19006222 S19006349
Products Sold
Lot Numbers: S18013318 S18010936 S19006220 S19006221 S19006222 S19006349
Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India is recalling Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 due to Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing cathe. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Recommended Action
Per FDA guidance
An Urgent Field Safety Notice dated 3/17/20 was sent to customers. Please immediately follow the Required Customer Actions set fo rth below. 1. Please forward this information to the immediate attention of the persons responsible for usage of the affected parts. Sub-recall must be initiated by your company to collect any distributed product from the suspected list. 2. Please fill in the attached Recall Response form and indicate the quantity of the affected product in your possession. 3. Please promptly return the completed Recall Response fo rm to Degania Silicone by e-mail: kkayam@qco.net. 4. The disposition of the recalled goods should be scrap. We would ask you to destruct the goods at your facil ity and send us the Scrap confirmation letter. Should you have any questions about this subject, please contact Degania Silicone: Degonia Silicone Ltd. Degania Bet, 1513000, ISRAEL Katia Kayam, Cust omer compla ints Officer Tel: +972-529532059 E-mail: kkayam@qco.net
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026