medical Class II Updated 2018-09-26

Degania Silicone, Ltd. recalls Foley Catheter with temperature sensor 400TM 16FR, Catalogue

Recalled Product

Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY 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: S17002091, S17002440, S17001607, S17002441, S17002558, S17002559, S17002561, S17002562, S17002563, S17002681, S17003391, S17004379, S17002560, S17002682, S17003456, S17003219, S17003301, S17003302, S17004772, S17004376, S17004377, S17004378, S17005117, S17005029, S17005281, S17005983, S17006720, S17004509, S17004510, S17004511, S17004771, S17004902, S17005028, S17005030, S17005529, S17005984, S17005985, S17004380, S17005979, S17006723, S17005980, S17005981, S17005982, S17005986, S17006718, S17006719, S17006721, S17006722, S17006724, S17006725, S17007360, S17007459, S17007622, S17002986, S17006363, S17007623, S17002987, S17007806, S17008017, S17002090

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