BEUDAMED
    FDA Enforcement Class II Terminated

    Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 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: P4P16TSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

    Recall: Z-1990-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1990-2020
    Event ID
    85629
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    April 30, 2020
    Classification Date
    May 14, 2020
    Termination Date
    December 14, 2023
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 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: P4P16TSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

    Reason

    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

    Code Info

    Lot Numbers: 1826714264, 1908533364, 1909302964, 1909303064, 1910654864, 1911300664, 1916240464, 1921106564, 1922533864, 2004908564, 2005617264, 2006339564

    Distribution

    US Nationwide distribution.

    Quantity

    23587 units