Events

Recall of Device Recall Hobbs Bronchial Cytology Brushes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hobbs Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79903
  • Event Risk Class
    Class 2
  • Event Number
    Z-2052-2018
  • Event Initiated Date
    2018-05-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163898
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    endoscopic cytology brush - Product Code FDX
  • Reason
    Device was marketed for uses outside the 510(k) clearance.
  • Action
    The firm, Hobbs Medical, Inc., sent an "Voluntary Medical Device Recall Advisory Notice" letter to customers on 5/1/18. The letter described the product, problem and actions to be taken. Our records indicate that you have received the following Bronchial Cytology Brushes since the beginning of 2018: Please complete the quantity used and quantity returned section of the attached form and you may voluntarily return any unused device(s) referencing Return Authorization Number. Hobbs Medical will credit your account in a timely fashion. f you have any questions, please contact customer service at 800-344-6227.

Device

Device Recall Hobbs Bronchial Cytology Brushes
  • Model / Serial
    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
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
  • Product 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.
  • Manufacturer
    Hobbs Medical, Inc.

Manufacturer

Hobbs Medical, Inc.
  • Manufacturer Address
    Hobbs Medical, Inc., 8 Spring St, Stafford Springs CT 06076-1505
  • Manufacturer Parent Company (2017)
    Hobbs Medical Inc.
  • Source
    USFDA