Degania Medical Devices Pvt. Ltd. recalls Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone cat…

Recall date

March 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1784-2020

FDA classification

Class II

Brand / firm

Degania Medical Devices Pvt. Ltd.

Sold / distributed

Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.

Why it was recalled

Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.