medical Class II Updated 2018-09-26

Degania Silicone, Ltd. recalls Foley Catheter with temperature sensor 400TM 14FR, Catalogue

Recalled Product

Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

Hazard / Issue

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: S17001226, S17002082, S17002550, S17002784, S17002883, S17002884, S17005004, S17003784, S17003785, S17002982, S17002983, S17003916, S17003917, S17004351, S17005957, S17006689, S17007029, S17004746, S17004877, S17005956, S17004486, S17006334, S17005958, S17006206, S17006333, S17006687, S17006688, S17000191, S17000192, S17000231, S17000320, S17000345, S17006690, S17006926, S17007030, S17007032, S17007334, S17007433, S17007434, S17007588, S17008088, S17005116, S17007031, S17003446, S17007599, S17007780, S17000335, S17002083
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