BEUDAMED
    FDA Enforcement Class II Terminated

    Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.

    Recall: Z-2052-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2052-2018
    Event ID
    79903
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hobbs Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 13, 2018
    Initiation Date
    May 1, 2018
    Classification Date
    June 1, 2018
    Termination Date
    April 10, 2020
    Address
    8 Spring St, N/A, Stafford Springs, CT, 06076-1505, United States

    Description

    Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.

    Reason

    Device was marketed for uses outside the 510(k) clearance.

    Code Info

    H07-17-157 H12-17-004 H10-17-055 H12-17-062 H11-17-101 H12-17-062 H11-17-119 H12-17-064 H11-17-120 H12-17-064 H11-17-121 H12-17-065 H11-17-122 H12-17-066 H11-17-123 H12-17-067 H11-17-124 H01-18-095 H11-17-125 H01-18-096 H11-17-126 H01-18-097 H11-17-127 H01-18-097 H11-17-128 H01-18-098 H11-17-129 H01-18-098 H11-17-130 H01-18-098 H12-17-002 H01-18-099 H12-17-003 H01-18-100 H12-17-003 H01-18-101 H01-18-102

    Distribution

    US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.

    Quantity

    1820 devices