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FDAJune 21, 2018device

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 si...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

degania siliconedegania

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 si... — Recall Details · AllClear