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Degania Medical Devices Pvt. Ltd. recalls Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone cath
Recalled April 29, 2020 · FDA recall Z-1782-2020 · Degania Medical Devices Pvt
Hazard
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. · FDA Class II
Units
16393
Sold at
Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
Description
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Manufacturer(s)
Degania Medical Devices Pvt. Ltd.
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →