medical Class II Updated 2020-05-20

Covidien Llc recalls Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch

Recalled Product

Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - 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: 1909308664, 1909320964 1933802964
View official government recall

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