Events

Recall of Kendall

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kendall Healthcare Products Co.

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
    30196
  • Event Risk Class
    Class 2
  • Event Number
    Z-0099-05
  • Event Initiated Date
    2004-10-08
  • Event Date Posted
    2004-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35388
  • 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
    Needle, Hypodermic, Single Lumen - Product Code FMI
  • Reason
    Needle cannula may separate from the hub during use.
  • Action
    Recall letters requesting product return were mailed to all customers on October 8, 2004

Device

Kendall
  • Model / Serial
    Lot numbers in the range of 406100 through 424600 (inclusive
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1.5 inch || Product Number: 5551833215
  • Manufacturer
    Kendall Healthcare Products Co

Manufacturer

Kendall Healthcare Products Co
  • Manufacturer Address
    Kendall Healthcare Products Co, 15 Hampshire St, Mansfield MA 02048-1113
  • Source
    USFDA