Covidien Llc recalls Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm…

Recall date

April 30, 2020

Source

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

Recall number

Z-1991-2020

FDA classification

Class II

Brand / firm

Covidien Llc

Sold / distributed

US Nationwide distribution.

Why it was recalled

Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment

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

What was recalled

Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.