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 102201101663MD - 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: V18007422 V18010291 V18023106 V18023107 V18023108 V18023109 V18025115 V18025117 V18025118 V18025119 V18026073 V18037032 V18026072 V18035228 V18035229 V18036131 V18037031 V18037033 V18037938 V19001678 V19001679 V19002478 V19002479 V19002480 V19013333 V19025876 V19026564 V19027234 V19027235 V19016726
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