medical Class II Updated 2020-04-29

Degania Medical Devices Pvt. Ltd. recalls Temperature Sensing 100% Silicone Foley Catheter, Part Numbe

Recalled Product

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

Hazard / Issue

Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: S18012796
View official government recall

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