Events

Recall of Device Recall DressitX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rainbow Specialty & Health Products.

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
    72726
  • Event Risk Class
    Class 2
  • Event Number
    Z-0477-2016
  • Event Initiated Date
    2015-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142039
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • Reason
    Rainbow specialty & health products initiated a field action for dressol-x and dressit-x because the labeling does not currently list the percentage of drug components.
  • Action
    Consignees have been made aware of the recall by FAX, e-mail and via telephone calls on 11/18/2015. Requested that distributors contact their clients, by telephone initially and then by email with written correspondence requesting them to recall the product from their clients.

Device

Device Recall DressitX
  • Model / Serial
    Lot - 5012, Exp-102016
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. No foreign, govt/VA/military consignees.
  • Product Description
    Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
  • Manufacturer
    Rainbow Specialty & Health Products

Manufacturer

Rainbow Specialty & Health Products
  • Manufacturer Address
    Rainbow Specialty & Health Products, 3400 14th Ave, Unit #28, Markham Canada
  • Source
    USFDA