Events

Recall of Kendall Monoject

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kendall a Division of Tyco Healthcare Group LP.

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
    36299
  • Event Risk Class
    Class 2
  • Event Number
    Z-0051-2007
  • Event Initiated Date
    2006-09-11
  • Event Date Posted
    2006-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48369
  • 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
    Monoject Syringe with Hypodermic Needle, - Product Code FMF
  • Reason
    Incorrect needle: there is an incorrect needle configuration on the syringe. the correct needle has a 27 gage a-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.
  • Action
    A recall letter was mailed 9/12/2006 to the 44 customers who purchased this product from Tyco Healthcare. The firm requested that their distributors notify their customers, and coordinate recovery of the product. The recall mailing included a form that was to be faxed back to Tyco Healthcare. A postage paid return envelope was also included if the customer does not have access to a fax machine.

Device

Kendall Monoject

Manufacturer

Kendall a Division of Tyco Healthcare Group LP
  • Manufacturer Address
    Kendall a Division of Tyco Healthcare Group LP, 5439 State Route 40, Argyle NY 12809-3830
  • Source
    USFDA