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 102203101663DO - 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: V18024145 V18024144 V18027064 V18026042 V18026043 V18026045 V18029205 V18029206 V18037913 V18049310 V19007111 V19007110 V19008666 V19008664 V19009594 V19013277 V19027814 V19027863 V19027865
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