FDA-Device2020-04-29Class II
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.
Degania Medical Devices Pvt. Ltd.
Hazard
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Sold states
Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
Affected count
2500
Manufactured in
Plot No 251, Imt Manesar, Gurgaon, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1779-2020Don't want to check this manually?
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