medical Class II Updated 2020-05-20

Covidien Llc recalls Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Me

Recalled Product

Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 1828206564, 1828813264 1829618264, 1829618364 1831001964, 1906506564 1907134164, 1909308864 1919705064, 1921106664 2000723764, 2003520164 2005617664
View official government recall

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